sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 3 ]

51

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

true

The primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until disease progression or unacceptable toxicity. This medication will be given over 10 minutes and may be administered intravenously (IV), through a vein in your arm. Vitamin supplementation is a required part of this study.

null

Ovarian Cancer Peritoneal Cancer

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 900 mg/m2, intravenous (IV), every 21 days, until disease progression

intervention 1: pemetrexed

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00461786

[ 5 ]

1,392

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The primary objective of this study is to compare, the number of patients with heartburn and regurgitation symptom resolution after treatment with either rabeprazole 20 mg, esomeprazole 20 mg or esomeprazole 40 mg.

The study is designed to be conducted in a realistic General Practice (GP) setting, enrolling typical Gastro-oesophageal Reflux Disease (GORD) patients that present for treatment, and for whom a Proton Pump Inhibitor (PPI) would normally be prescribed. The study will be conducted over a 4-week period on the basis that current GP standard practice is to treat the GORD patient for a period of 4-weeks prior to reassessment and further follow-up if required. This study is conducted in patients with GORD - associated heartburn (with or without regurgitation) at multiple GP centers, treatment is assigned based on chance (randomized), similar to the toss of a coin and neither doctor or patient knows which treatment they will receive (double-blinded). Following screening to determine eligibility, patients will be randomized to receive oral treatment with either, 20 mg rabeprazole, 20 mg esomeprazole or 40 mg esomeprazole once daily for 4 weeks. This 4-week study encompasses 2 protocol-mandated visits (baseline on day 0 and final visit on day 28). It is hypothesized that rabeprazole 20 mg will be no less effective than (non-inferior) esomeprazole 40 mg for the degree of GORD symptom resolution. Patients will take one tablet (rabeprazole 20 mg or placebo) and one capsule (esomeprazole 20 mg, esomeprazole 40 mg or placebo) each day for 28 days. The study medication will be taken once daily in the morning before breakfast, except the first dose, which will be taken during Visit 1.

Gastro-oesophageal Reflux

Gastroesophageal Reflux Heartburn Proton pump inhibitor GORD

null

3

arm 1: Esomeprazole 40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily arm 2: Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily arm 3: Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

[ 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily intervention 2: 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily intervention 3: 40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

intervention 1: Esomeprazole intervention 2: Rabeprazole intervention 3: Esomeprazole

25

Belconnen | N/A | Australia | 149.06627 | -35.23798 Bondi Junction | N/A | Australia | 151.24723 | -33.89275 Brookvale | N/A | Australia | 151.27446 | -33.76108 Browns Plains | N/A | Australia | 146.63866 | -36.0472 Campbelltown | N/A | Australia | 150.81667 | -34.06667 Campsie | N/A | Australia | 151.10279 | -33.9125 Caringbah | N/A | Australia | 151.12468 | -34.03534 Castle Hill | N/A | Australia | 151.0 | -33.73333 Charlestown | N/A | Australia | 151.69318 | -32.96828 Dapto | N/A | Australia | 150.79416 | -34.50386 Darlinghurst | N/A | Australia | 151.21925 | -33.87939 Dubbo | N/A | Australia | 148.60484 | -32.24295 Elizabeth | N/A | Australia | 138.67 | -34.72 Fairfield | N/A | Australia | 150.95 | -33.86667 Hoppers Crossing | N/A | Australia | 144.7003 | -37.88264 Ingleburn | N/A | Australia | 150.86667 | -34.0 Leichhardt | N/A | Australia | 151.15625 | -33.88341 Maroubra | N/A | Australia | 151.23333 | -33.95 Melton | N/A | Australia | 144.58543 | -37.68339 Mount Druitt | N/A | Australia | 150.81667 | -33.76667 Oaklands Park | N/A | Australia | 138.54457 | -35.00671 Royal Park | N/A | Australia | 138.51189 | -34.87415 Sydney | N/A | Australia | 151.20732 | -33.86785 Wentworthville | N/A | Australia | 150.96785 | -33.80652 Wyoming | N/A | Australia | 151.36254 | -33.40387

0

NCT00464308

[ 4 ]

216

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeomin).

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins. Injected into a muscle, incobotulinumtoxinA causes a reversible local weakening of the muscle for several months, and may improve an impaired muscle function by lessening the muscle tightness within few days. IncobotulinumtoxinA is widely used for various severe neurological conditions. There is some evidence that the treatment effect may be influenced by the amount of the solvent in which incobotulinumtoxinA is diluted before injection.

Upper Limb Spasticity

null

2

arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 5.0 mL resulted in a dose of 20 units per 1.0 mL. arm 2: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 mL sterile of NaCl 0.9% solution without preservatives. Dilution with 2.0 mL resulted in a dose of 50 units per 1.0 mL.

[ 0, 1 ]

1

[ 0 ]

intervention 1: active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.

intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")

27

Hermagor | N/A | Austria | 13.36722 | 46.62722 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Vienna | N/A | Austria | 16.37208 | 48.20849 Besançon | N/A | France | 6.01815 | 47.24878 Garches | N/A | France | 2.18232 | 48.84226 Lille | N/A | France | 3.05858 | 50.63297 Paris | N/A | France | 2.3488 | 48.85341 Beelitz-Heilstätten | N/A | Germany | 12.92662 | 52.25965 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Gladbeck | N/A | Germany | 6.98593 | 51.57077 Bari | N/A | Italy | 16.86982 | 41.12066 Costa Masnaga | N/A | Italy | 9.27632 | 45.76963 Messina | N/A | Italy | 15.55256 | 38.19394 Mestre | N/A | Italy | 12.24538 | 45.49167 Milan | N/A | Italy | 12.59836 | 42.78235 Rome | N/A | Italy | 12.51133 | 41.89193 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Tocha | N/A | Portugal | -8.75339 | 40.31308 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Terrassa | N/A | Spain | 2.01667 | 41.56667 Bern | N/A | Switzerland | 7.44744 | 46.94809 Nottwil | N/A | Switzerland | 8.13774 | 47.13469 Kent | N/A | United Kingdom | 0.52021 | 51.27893 Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 Plymouth | N/A | United Kingdom | -4.14305 | 50.37153 Wakefield | N/A | United Kingdom | -1.49768 | 53.68331

0

NCT00465738

[ 4 ]

122

RANDOMIZED

PARALLEL

1PREVENTION

1SINGLE

false

0ALL

false

Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery carried out in children who very often also present with obstructive sleep apnea. To provide pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl. These narcotics are known to depress respiration and to increase the incidence of post-operative nausea and vomiting. These side effects are worrisome in this patient cohort. An alternative medication, dexmedetomidine, may have an opiate sparing effect and has a high safety profile in adults as well as in sedation in children. The purpose of this study is to determine if intravenous dexmedetomidine given as an infusion during general anesthesia for tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence agitation, improves analgesia and reduces nausea and vomiting in the 60 minutes following surgery.

Emergence agitation (EA) from general anesthesia is a frequent phenomenon in children age 1-10 yrs recovering from anesthesia that demands increasing nursing care in the PACU, delays reunion with parents and often causes dissatisfaction for parents, and may lead to adverse sequelae in some cases such as physical harm to the child, in particular to the site of surgery (1). Emergence agitation is a state of non purposeful restlessness an inconsolability. This state is often accompanied by thrashing, screaming, prolonged crying and disorientation. Children are generally unaware of their surroundings and cannot be consoled by the caregivers/parents. It is very disturbing for parents to observe this behavior in their children. It is also a safety issue for children and staff. These negative effects of EA have motivated clinicians to investigate possible etiologies and potential treatments for EA. EA may be in part due to the relative paucity of inhibitory neurotransmitters in children's central nervous system (CNS). As well, all modern anesthetics have been designed to be rapidly eliminated resulting in abrupt change from a state of anesthesia to a state of responsiveness. The result is a difficult problem managing these patients over a 30-50 minute period following pediatric anesthesia. We propose studying patients scheduled for tonsillectomy or adenotonsillectomy. Adenotonsillar hypertrophy may produce upper airway obstruction, dysphagia, dental malocclusion, altered orofacial growth, altered eustachian tube function, or pulmonary hypertension with cor pulmonale. Obstructive sleep apnea (OSA) is associated with loud snoring during sleep with periods of respiratory pauses terminated with gasping and agitated arousal and has been suggested to have developmental consequences including ADHD, failure to thrive, and nocturnal enuresis (2). Obstructive sleep apnea syndrome is most commonly associated with adenotonsillar hypertrophy and more children are now presenting for adenotonsillectomy (3). Tonsillectomy and adenotonsillectomy are highly successful in eliminating OSA in children and is considered first-line therapy if the family is amenable and there are no specific contraindications, and is approximately 85-95% effective in eliminating OSA in children (4). All children undergoing tonsillectomy or adenoidectomy should be considered to be at increased risk for perioperative airway problems (5). Opioids may cause respiratory depression, and thus present an added risk in patients undergoing tonsillectomy and adenotonsillectomy, especially in children with OSA (6). The purpose of this study is to determine if intravenous dexmedetomidine given as an infusion during general anesthesia for tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence agitation in the 60 minutes following surgery compared to normal practice. A second outcome is whether the need for intra-operative and postoperative analgesic narcotic medications is reduced. Dexmedetomidine, a specific alpha 2-adrenergic receptor agonist, has recently been studied for its sedative, amnestic, and analgesic properties and has been shown to be effective in providing sedation, decreased anesthetic requirements during surgery and in postanesthesia care units, and reduction in emergence agitation (7, 8, 9). Dexmedetomidine has been shown to enhance the analgesic action of nitrous oxide and furthermore it has also been shown to be effective as a total intravenous anesthetic agent in certain patients if doses are increased to a high enough level, with no respiratory depression (10, 11). If dexmedetomidine can be shown to reduce or eliminate emergence agitation, and provide effective intraoperative and postoperative analgesia without respiratory depression, this would give anesthesiologists a better option in the management of patients undergoing tonsillectomy and adenotonsillectomy. The dosing regimen for Dexmedetomidine in a loading dose of 1ug/kg with with a continuous infusion of 0.2-0.7 ug/kg is recommended for sedation in the Intensive Care Unit for adults. There is an increasing body of experience with use of Dexmedetomidine in pediatrics both for sedation and to reduce kg/hr. They observed a mean decline in heart rate (HR) and blood pressure (BP) from pre-sedation values of 15%, with 70% of patients showing a decline between 1-30%. Despite the drop in HR and BP, all changes were still within the clinical range of normal for age (10). We are proposing 2 ug/kg as a loading dose with a maintenance dose of 0.7ug/kg/hr during surgery, since we intend to use dexmedetomidine during tonsillectomy and adenotonsillectomy, a surgery which can stimulate a pain response and the surgery starts soon after the patient is intubated with no surgical preparation time . 2ug/kg is higher than the usual recommended dose, but has been used in children in the above study without any significant adverse events.

Obstructive Sleep Apnea

obstructive sleep apnea tonsillectomy adenoidectomy

null

2

arm 1: fentanyl bolus 1ug.kg-1 arm 2: dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion intervention 2: 1 microgram/kilogram as a bolus

intervention 1: dexmedetomidine intervention 2: fentanyl

1

Newark | New Jersey | United States | -74.17237 | 40.73566

0

NCT00468052

[ 5 ]

135

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.

Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related morbidities that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents. Zolpidem is the most commonly prescribed hypnotic in the United States for patients suffering from insomnia. The purpose of this study is to assess whether ramelteon therapy can facilitate the discontinuation of benzodiazepine therapy in long term users. Subject participation in this study is anticipated to be about 17 weeks. Subjects were screened and enrolled in a 4-week placebo run-in period, may have been randomized to a 10-week double-blind treatment period, and may have completed with a 2-week open-label treatment period. In the double-blind treatment period, subjects were randomized to one of two treatments: either ramelteon 8 mg tablets taken orally once-daily with concomitant current zolpidem therapy or to placebo-matching tablets once daily with concomitant current zolpidem therapy. Subjects incrementally reduced zolpidem therapy by dose, frequency, or both for up to 10 weeks. Only those subjects who completed the double-blind treatment period and had achieved a 50% reduction in zolpidem therapy during the double-blind treatment period participated in the open-label treatment period in which 8 mg ramelteon was administered. Zolpidem consumed during the open-label treatment period was recorded.

Chronic Insomnia

Chronic Insomnia Sleep Initiation and Maintenance Disorder Drug Therapy

null

2

arm 1: Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks. arm 2: Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks. intervention 2: Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.

intervention 1: Ramelteon and zolpidem intervention 2: Placebo and zolpidem

41

0

NCT00492232

[ 4 ]

217

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To assess the efficacy and safety of efficacy of MTS compared to placebo

To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.

ADHD

null

2

arm 1: dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear arm 2: Daily application of matching MTS Placebo Patch

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear intervention 2: Placebo patch

intervention 1: methylphenidate transdermal system intervention 2: Placebo

32

0

NCT00499863

[ 5 ]

22

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Patients who are admitted to subacute rehabilitation facilities following hospitalization are frequently anemic. The purpose of this study is to see if anemic patients treated with epoetin alfa will have higher hemoglobin levels and better functional recovery at 3, 8, and 12 weeks after study entry compared to patients who do not receive epoetin alfa.

Anemia is associated with loss of function in some studies. However, it is unknown if more rapid correction of anemia in patients who enter a rehabilitation setting after surgery or from hospitalization for acute medical problems leads to shorter rehabilitation stays and improved functional status. Patients aged 60 and older who have hemoglobin levels of less than 10.5 g/dL will be randomized to receive 8 weekly doses of either erythropoietin alfa or placebo. Functional status will be measured at baseline and then at 3, 8 and 12 weeks. The following specific aims will be tested in this study: * Determine the prevalence of anemia in patients admitted to a subacute rehabilitation facility with potential for recovery. * Determine the baseline functional status of patients admitted to a subacute rehabilitation facility with potential for recovery using the Functional Independence Measure (FIM), an assessment tool used in acute rehabilitation settings. * Determine if administration of epoetin alfa will result in higher hemoglobin concentrations in patients receiving the drug than in patients given placebo at 3, 8 and 12 weeks after entry into the study. * Perform a study that establishes the feasibility of a trial to test whether epoetin alfa produces improvements in the FIM, grip strength, the time it takes for patients to reach rehabilitation goals, activity monitor, fatigue, mood, functional recovery and reduces length of rehabilitation stay.

Anemia

anemia function rehabilitation

null

2

arm 1: Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks arm 2: 40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks

[ 2, 1 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: placebo intervention 2: epoetin alpha intervention 3: Niferex

2

0

NCT00511901

[ 3 ]

361

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.

A 16-week, parallel-group, double-blind, randomized, placebo-controlled, multicenter, dose-ranging study to evaluate the efficacy, safety and tolerability of multiple doses and multiple treatment regimens of Albiglutide (GSK716155) with Byetta as an open-label active reference, in subjects with Type 2 Diabetes Mellitus.

Diabetes Mellitus, Type 2

GLP-1, Type 2 Diabetes, pharmacokinetics, pharmacodynamics, GSK716155, metformin, exenatide Type 2 Diabetes Mellitus

null

0

null

1

[ 0 ]

intervention 1: Albiglutide weekly subcutaneous injection or exenatide twice daily injection

intervention 1: Albiglutide (GSK716155) or exenatide

163

0

NCT00518115

[ 3 ]

280

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and to see how safe PS433540 is compared to placebo.

null

Hypertension

hypertension high blood pressure

null

3

arm 1: Matching Placebo arm 2: None arm 3: None

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 200mg capsule, once daily for 28 days intervention 2: placebo capsule, once daily for 28 days intervention 3: 500mg capsule, once daily for 28 days

intervention 1: PS433540 intervention 2: placebo intervention 3: PS433540

15

0

NCT00522925

[ 3 ]

85

null

PARALLEL

0TREATMENT

null

false

0ALL

null

The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV) and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy and safety

null

HIV Infections

null

0

null

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: tipranavir intervention 2: ritonavir

12

Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 München | N/A | Germany | 13.31243 | 51.60698 Antella (fi) | N/A | Italy | 11.32233 | 43.72774 Bari | N/A | Italy | 16.86982 | 41.12066 Ferrara | N/A | Italy | 11.62057 | 44.83804 Palermo | N/A | Italy | 13.3636 | 38.1166 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 L'Hospitalet de Llobregat | N/A | Spain | 2.10028 | 41.35967 Madrid | N/A | Spain | -3.70256 | 40.4165

0

NCT00530920

[ 3 ]

222

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension

null

Glaucoma Ocular Hypertension

null

2

arm 1: bimatoprost eye drops arm 2: placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 1 drop in each eye daily for 1 month intervention 2: 1 drop in each eye daily for 1 month

intervention 1: bimatoprost eye drops intervention 2: placebo

1

Atlanta | Georgia | United States | -84.38798 | 33.749

0

NCT00538304

[ 4 ]

480

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (Head lice).

This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.

Pediculus Capitis Infestation

head lice

null

3

arm 1: NatrOVA Creme Rinse (spinosad) 1% - no nit combing required arm 2: NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required arm 3: Nix Creme Rinse (permethrin 1%) applied according to OTC Instructions for Use

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 10 minute topical application of product, followed by a complete rinse off. intervention 2: 10 minute topical application followed by a complete rinse off, followed by a nit combing regimen. intervention 3: Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen

intervention 1: Spinosad intervention 2: Spinosad intervention 3: Permethrin 1%

6

0

NCT00545168

[ 4 ]

558

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

false

A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (human head lice).

This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.

Pediculosis

Human Head lice

null

3

arm 1: NatrOVA Creme Rinse (spinosad) 1% - no nit combing required arm 2: NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required arm 3: NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 10 minute topical application product, following by a complete rinse off. intervention 2: 10 minute topical application followed by a complete rinse off, followed by a nit combing regimen intervention 3: Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen

intervention 1: Spinosad intervention 2: Spinosad intervention 3: Permethrin 1%

6

0

NCT00545753

[ 2, 3 ]

95

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection

null

Chronic Hepatitis C

null

4

arm 1: Daclatasvir - 1 mg Placebo - 0 mg arm 2: Daclatasvir - 10 mg Placebo - 0 mg arm 3: Daclatasvir - 100 mg Placebo - 0 mg arm 4: Daclatasvir - 0.5 - 200 mg (to be determined) Placebo - 0 mg

[ 1, 1, 1, 1 ]

2

[ 0, 0 ]

intervention 1: Oral Solution, Oral, Single Dose intervention 2: Oral Solution, Oral, Single Dose

intervention 1: Daclatasvir intervention 2: Placebo

7

0

NCT00546715

[ 3 ]

568

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

null

COPD

QMF indacaterol TWISTHALER® device

null

6

arm 1: Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 2: Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 3: Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 4: Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 5: Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 6: Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

[ 0, 0, 0, 0, 1, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device). intervention 2: Formoterol delivered by oral inhalation via AEROLIZER® inhalation device. intervention 3: Placebo TWISTHALER® device intervention 4: Placebo AEROLIZER® device intervention 5: 100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

intervention 1: indacaterol intervention 2: formoterol intervention 3: placebo to indacaterol intervention 4: placebo to formoterol intervention 5: short acting β2- agonist

75

Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Rosario | N/A | Argentina | -60.63932 | -32.94682 Santillán | N/A | Argentina | -58.97963 | -29.46546 Liège | N/A | Belgium | 5.56749 | 50.63373 Santiago | N/A | Chile | -70.64827 | -33.45694 Val Pariso | N/A | Chile | N/A | N/A Bois-Guillaume | N/A | France | 1.12219 | 49.4602 Clermot Ferand | N/A | France | N/A | N/A Lille | N/A | France | 3.05858 | 50.63297 Marseille | N/A | France | 5.38107 | 43.29695 Nantes | N/A | France | -1.55336 | 47.21725 Toulouse | N/A | France | 1.44367 | 43.60426 Berlin | N/A | Germany | 13.41053 | 52.52437 Bibertal | N/A | Germany | N/A | N/A Bochum | N/A | Germany | 7.21648 | 51.48165 Bonn | N/A | Germany | 7.09549 | 50.73438 Cologne | N/A | Germany | 6.95 | 50.93333 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Hamburg | N/A | Germany | 9.99302 | 53.55073 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Koblenz | N/A | Germany | 7.57883 | 50.35357 Marburg | N/A | Germany | 8.77069 | 50.80904 Solingen | N/A | Germany | 7.0845 | 51.17343 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Pécs | N/A | Hungary | 18.23083 | 46.0725 Dublin | N/A | Ireland | -6.24889 | 53.33306 Genova | N/A | Italy | 11.87211 | 45.21604 Napoli | N/A | Italy | 14.5195 | 40.87618 Pordenone | N/A | Italy | 12.66051 | 45.95689 Daugavpils | N/A | Latvia | 26.53333 | 55.88333 Riga | N/A | Latvia | 24.10589 | 56.946 Kaunas | N/A | Lithuania | 23.90961 | 54.90272 Klaipėda | N/A | Lithuania | 21.13912 | 55.7068 Vilnius | N/A | Lithuania | 25.2798 | 54.68916 Tronheim | N/A | Norway | N/A | N/A Lima | N/A | Peru | -77.02824 | -12.04318 Izabelin | N/A | Poland | 20.81729 | 52.29992 Lodz | N/A | Poland | 19.47395 | 51.77058 Lublin | N/A | Poland | 22.56667 | 51.25 Mrozy | N/A | Poland | 21.80263 | 52.16609 Olsztyn | N/A | Poland | 20.49416 | 53.77995 Rzeszów | N/A | Poland | 21.99901 | 50.04132 Wejhrowo | N/A | Poland | N/A | N/A Włocławek | N/A | Poland | 19.0678 | 52.64817 Bucharest | N/A | Romania | 26.10626 | 44.43225 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Iași | N/A | Romania | 27.6 | 47.16667 Timișoara | N/A | Romania | 21.22571 | 45.75372 Bloemfontain | N/A | South Africa | N/A | N/A Bloemfontein | N/A | South Africa | 26.214 | -29.12107 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Durban | N/A | South Africa | 31.0292 | -29.8579 eManzimtoti | N/A | South Africa | 30.88527 | -30.05219 George | N/A | South Africa | 22.46173 | -33.963 Johannesburg | N/A | South Africa | 28.04363 | -26.20227 Port Elizabeth | N/A | South Africa | 25.61494 | -33.96109 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Tygerberg | N/A | South Africa | N/A | N/A Erzurum | N/A | Turkey (Türkiye) | 41.27694 | 39.90861 Isparta | N/A | Turkey (Türkiye) | 30.55222 | 37.76444 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Kahramanmaraş | N/A | Turkey (Türkiye) | 36.92641 | 37.5847 Kayseri | N/A | Turkey (Türkiye) | 35.48528 | 38.73222 Malatya | N/A | Turkey (Türkiye) | 38.31667 | 38.35018 Manisa | N/A | Turkey (Türkiye) | 27.42647 | 38.61202 Sanliurfa | N/A | Turkey (Türkiye) | 38.79392 | 37.16708 Trabzon | N/A | Turkey (Türkiye) | 39.72694 | 41.005 Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Chesterfield | N/A | United Kingdom | -1.41667 | 53.25 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Plymouth | N/A | United Kingdom | -4.14305 | 50.37153 Warminster | N/A | United Kingdom | -2.17873 | 51.20434 Watford | N/A | United Kingdom | -0.39602 | 51.65531 Whitstable | N/A | United Kingdom | 1.0257 | 51.3607

0

NCT00557466

[ 4 ]

156

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The objectives of this trial conducted in early Parkinson's disease (PD) patients are: * To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal; * To establish if this successful switch can be obtained with or without dose-adaptation; * To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.

null

Parkinson Disease

null

2

arm 1: Pramipexole Extended Release (ER) once daily arm 2: Pramipexole Immediate Release (IR) once daily

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Pramipexole Extended Release intervention 2: Pramipexole Immediate Release

36

Aix-en-Provence | N/A | France | 5.44973 | 43.5283 Aix-en-Provence | N/A | France | 5.44973 | 43.5283 Aix-en-Provence | N/A | France | 5.44973 | 43.5283 Bron | N/A | France | 4.91303 | 45.73865 Clermont-Ferrand | N/A | France | 3.08682 | 45.77969 Créteil | N/A | France | 2.46569 | 48.79266 Créteil | N/A | France | 2.46569 | 48.79266 Dijon | N/A | France | 5.01667 | 47.31667 Évreux | N/A | France | 1.15082 | 49.02414 Lille | N/A | France | 3.05858 | 50.63297 Lille | N/A | France | 3.05858 | 50.63297 Lille | N/A | France | 3.05858 | 50.63297 Lille | N/A | France | 3.05858 | 50.63297 Marseille | N/A | France | 5.38107 | 43.29695 Marseille | N/A | France | 5.38107 | 43.29695 Montpellier | N/A | France | 3.87635 | 43.61093 Rouen | N/A | France | 1.09932 | 49.44313 Rouen | N/A | France | 1.09932 | 49.44313 Strasbourg | N/A | France | 7.74553 | 48.58392 Toulouse | N/A | France | 1.44367 | 43.60426 Toulouse | N/A | France | 1.44367 | 43.60426 Toulouse | N/A | France | 1.44367 | 43.60426 Achim Bei Bremen | N/A | Germany | N/A | N/A Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Gera | N/A | Germany | 12.08187 | 50.88029 Karlsruhe | N/A | Germany | 8.40444 | 49.00937 Steglitz | N/A | Germany | 13.332 | 52.45606 Unterhaching | N/A | Germany | 11.61564 | 48.06598 's-Hertogenbosch | N/A | Netherlands | 5.30417 | 51.69917 Geldrop | N/A | Netherlands | 5.55972 | 51.42167 Helmond | N/A | Netherlands | 5.66111 | 51.48167 Maastricht | N/A | Netherlands | 5.68889 | 50.84833 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Sittard | N/A | Netherlands | 5.86944 | 50.99833

0

NCT00558025

[ 4 ]

91

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The purpose of this study conducted in Asia-Pacific was to evaluate the efficacy and safety of Sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for chemonaive patients with unresectable stage IIIB (with effusion) or stage IV NSCLC. However, as indicated below, the study was terminated prematurely when the results from Study 11961 (NCT00300885), an earlier Phase 3 study of similar design in subjects with advanced NSCLC, showed an overall lack of efficacy and increased mortality in subjects with squamous subtype. The data available is presented as descriptive analyses, due to the limitations of implementing the statistical analysis plan.

The study was terminated early when the results from Study 11961 (NCT00300885), an earlier Phase 3 study evaluating the effects of Sorafenib in combination with paclitaxel and carboplatin in subjects with advanced NSCLC, showed an overall lack of efficacy of Sorafenib in combination with paclitaxel and carboplatin in NSCLC and increased mortality in subjects with squamous subtype.

Carcinoma, Non-Small-Cell Lung

NSCLC

null

2

arm 1: Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days. arm 2: Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days. intervention 2: Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days

intervention 1: Sorafenib + Paclitaxel + Carboplatin intervention 2: Placebo + Paclitaxel + Carboplatin

22

0

NCT00558636

[ 5 ]

40

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study is designed to examine how pregabalin affects parameters of autonomic nerve regulation in correlation with change in pain, anxiety, and depressive symptoms in patients with diabetic neuropathy.

This study is designed to primarily examine how pregabalin affects the autonomic nerve or sympathetic-parasympathetic regulation in patients with diabetic neuropathy and its relationship to neuropathic pain. The goals of this study include (1) assessing the change of parameters of autonomic nerve function such as heart rate variability (HRV), respiratory sinus arrhythmia (RSA), minute ventilation, and changes in objective sleep parameters measured by means of the LifeShirt, upon treatment of pregabalin in comparison to placebo; (2) assessing the symptom change of neuropathic pain upon treatment of pregabalin in comparison to placebo; (3) assessing the change of anxiety symptoms upon treatment of pregabalin in comparison to placebo; (4) assessing the change of depressive symptoms upon treatment of pregabalin in comparison to placebo; (5) assessing the relationship of autonomic nerve function with neuropathic pain at baseline prior to treatment and the correspondences to the study drug; (6) assessing the relationship of autonomic nerve function with anxiety and depressive symptoms at baseline prior to treatment and their correspondences to the study drug; (7) identifying sensitive and reliable parameters of autonomic nerve regulation as predictor(s) of the severity and improvement of neuropathic pain and/or anxiety; and (8) to assess the change in objective sleep parameters (EEG/EOG) by means of the LifeShirt, upon treatment of pregabalin in comparison to placebo

Diabetic Neuropathy

Diabetic neuropathy Pregabalin Lyrica

null

2

arm 1: Pregabalin medication arm 2: Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day. intervention 2: Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.

intervention 1: Pregabalin intervention 2: Placebo

1

Durham | North Carolina | United States | -78.89862 | 35.99403

0

NCT00573261

[ 2, 3 ]

25

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

false

The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on estimating the percentage of women who experience an improvement in their urinary incontinence symptoms at one month and three months following this novel instillation technique.

Rationale: To date, the standard treatment for overactive bladder (including detrusor hyperreflexia and detrusor overactivity) consists of oral anticholinergic medications that can have troublesome side effects and variable efficacy. What's more, patients failing pharmacological therapy must either live with their malady or undergo open surgery that is irreversible and carries a prolonged convalescence. The fact remains however that treatment for overactive bladder is necessary to help maintain quality of life and prevent upper urinary tract deterioration. In recent years, cystoscopic-guided injection of Botulinum-A toxin has been used as a novel method of addressing detrusor hyperreflexia and overactivity by blocking acetylcholine transmission at the bladder. The obvious benefits of a more targeted therapy notwithstanding, this method requires the use of a cystoscope, needle delivery of the agent through approximately 30 separate injection sites and either regional or topical intravesical anesthesia for peri-operative pain control. Clearly, the identification of less invasive and more cost effective means of delivering the beneficial effects of Botulinum-A toxin to the bladder muscle has the potential to enhance the overall appeal of this treatment method. Objectives: The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on estimating the percentage of women who experience an improvement in their urinary incontinence symptoms at one month and three months following this novel instillation technique. Study Design: We are proposing a single center, Phase II pilot study for this investigation. In this proposal, 25 sterile women between 18-90 years of age with urodynamic evidence of detrusor overactivity, hyperreflexia or symptoms of overactive bladder syndrome who lack evidence of infection and stress incontinence will be offered bladder instillation of Botulinum-A toxin with DMSO as a carrier agent if they have failed anticholinergic medications or cannot tolerate the pharmacological side effects. We will use two validated measurement tools for determining urinary incontinence severity. These measurement tools will be administered to each women at baseline and then again at one month and three-month follow-up time points. Our analysis will also focus on identifying and describing adverse events among these women and estimating the percentage of women that experience a successful improvement in their urinary incontinence symptoms. Study Duration: Patients will sign an informed consent and be screened for eligibility. Once determined eligible for the study, each patient will be scheduled for baseline evaluation and instillation of Botox/DMSO. Patients will be then followed up at one month and three months. Patients will be removed from the study if they withdraw consent, experience one of the study stopping criteria (in which case the entire study will stop) or when they complete the final follow-up evaluation at three-months.

Overactive Bladder Detrusor Instability Detrusor Hyperreflexia

null

1

arm 1: Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.

[ 0 ]

2

[ 0, 0 ]

intervention 1: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution. intervention 2: Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO.

intervention 1: Botulinum-A toxin intervention 2: Dimethyl sulfoxide (DMSO)

1

Jacksonville | Florida | United States | -81.65565 | 30.33218

0

NCT00583219

[ 3 ]

18

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

true

For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation.

For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators decided to use blood drawn from the patient for injection under the lesion. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation. Blood can also have local hemostatic action preventing from bleeding during polypectomy.

Large Polyps in the Gastrointestinal Tract

submucosal cushion polypectomy endoscopic mucosal resection

null

3

arm 1: Polypectomy with normal saline injected for submucosal cushion creation arm 2: Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion arm 3: Polypectomy after injection of autologous blood

[ 1, 1, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion intervention 2: Normal saline will be injected under the lesion to create submucosal cushion intervention 3: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion

intervention 1: Autologous blood injection intervention 2: Normal saline intervention 3: HPMC

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00583466

[ 4 ]

39

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic renal cell carcinoma (RCC) to assess the pharmacokinetic profile, safety and tolerability, and efficacy.

null

Carcinoma, Renal Cell

Sorafenib Nexavar Metastatic RCC Renal Cell Carcinoma Unresectable RCC

null

1

arm 1: 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)

[ 0 ]

1

[ 0 ]

intervention 1: 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)

intervention 1: Sorafenib (Nexavar, BAY43-9006)

8

Nanjing | Jiangsu | China | 118.77778 | 32.06167 Beijing | N/A | China | 116.39723 | 39.9075 Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 Tainan City | Tainan | Taiwan | 120.21333 | 22.99083 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896

0

NCT00586105

[ 4 ]

861

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

Safety study for bepotastine besilate ophthalmic solution in normal volunteers

null

Allergic Conjunctivitis

null

2

arm 1: bepotastine besilate ophthalmic solution 1.5% arm 2: vehicle

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: One drop, both eyes, twice a day intervention 2: One drop, both eyes, twice a day

intervention 1: Bepreve intervention 2: Placebo

0

null

0

NCT00586625

[ 3 ]

132

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.

Delayed sleep phase syndrome is the most common circadian disorder in adolescents and most adults with the condition report onset of symptoms during childhood or adolescence. Delayed Sleep Phase Syndrome involves a chronic mismatch between the usual daily schedule required by the individual's environment and his or her circadian sleep wake pattern. Individuals suffering from delayed Sleep Phase Syndrome experience great difficulty when attempting to fall asleep before 1-2 am, if not later, as well as rising at acceptable hours of the morning despite having completely normal sleep architecture and sleep duration. Delayed Sleep Phase Syndrome is a sleep disorder that results from a dysregulation of the circadian sleep-wake rhythm. Delayed Sleep Phase Syndrome is often the cause of severe insomnia and is associated with excessive daytime sleepiness, major depressive disorder and severe disruption of education, work and social functioning. Its major symptom is extreme difficulty initiating sleep at a conventional hour and waking on time in the morning for school or work. Ramelteon is a selective melatonin type 1 (MT1) and type 2 (MT2) receptor agonist. The purpose of this study is to evaluate the ability of ramelteon to advance the timing of sleep in individuals with delayed sleep phase syndrome. The effect of ramelteon will be analyzed based on collection of information from a post-sleep questionnaire completed by participants, and data collected by polysomnography in a sleep clinic setting. Total participation time involved in this study will be approximately 7 weeks.

Sleep Disorders, Circadian Rhythm

Delayed sleep phase syndrome; drug therapy

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Ramelteon 1 mg, tablets, orally, once daily for up to two weeks. intervention 2: Ramelteon 4 mg, tablets, orally, once daily for up to two weeks. intervention 3: Ramelteon 8 mg, tablets, orally, once daily for up to two weeks. intervention 4: Ramelteon placebo-matching tablets, orally, once daily for up to two weeks.

intervention 1: Ramelteon intervention 2: Ramelteon intervention 3: Ramelteon intervention 4: Placebo

42

0

NCT00593736

[ 5 ]

14

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Evaluation of efficacy and safety on the use of rotigotine in patients suffering from Parkinson's Disease during and after surgery requiring general anaesthesia.

null

Parkinson's Disease

Rotigotine NEUPRO® Parkinson's Disease (PD) perioperative use anaesthesia,

null

1

arm 1: Rotigotine

[ 0 ]

1

[ 0 ]

intervention 1: 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h patch; Single patches and a combination of 2 of these patches for a dosage of up to 16 mg/24 h; One (1) regimen on day of surgery, but exceptionally extended for up to 2 (two) weeks if the patient requires unexpected ventilation after surgery.

intervention 1: Rotigotine

12

Augsburg | N/A | Germany | 10.89851 | 48.37154 Bochum | N/A | Germany | 7.21648 | 51.48165 Bonn | N/A | Germany | 7.09549 | 50.73438 Bremerhaven | N/A | Germany | 8.57553 | 53.55357 Dortmund | N/A | Germany | 7.466 | 51.51494 Dresden | N/A | Germany | 13.73832 | 51.05089 Hanau | N/A | Germany | 8.91418 | 50.13423 Ingolstadt | N/A | Germany | 11.42372 | 48.76508 Kiel | N/A | Germany | 10.13489 | 54.32133 Schwerin | N/A | Germany | 11.41316 | 53.62937 Stralsund | N/A | Germany | 13.0818 | 54.30911 Ulm | N/A | Germany | 9.99155 | 48.39841

0

NCT00594464

[ 4 ]

117

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

null

The objective of this study is to test the idea that the immediate-release (IR) form of tapentadol (CG5503) can be directly converted into an approximately equivalent total daily dose (TDD) of the extended-release (ER) form, and vice-versa, with equivalent safety and efficacy.

This study will establish the dose equivalence and the safety and effectiveness of the Immediate Release (IR) and Extended Release (ER) forms of tapentadol (CG5503) to support the conversion from IR to ER, and ER to IR use. Dose equivalence will be examined in patients diagnosed with moderate-to-severe, chronic Low Back Pain (LBP) requiring drug treatment for at least 3 months, and who are dissatisfied with current therapy. The study consists of 5 periods: a screening period during which patients are evaluated for study eligibility; a 21-day open-label period to find the best, stable dose of tapentadol (CG5503) IR for each patient individually; a 14-day double-blind period when patients are randomly chosen either to continue for 14 days on the stable IR dose from the open-label period or switch to the ER form; a second, 14-day period during which patients switch to whichever form of tapentadol (CG5503) they did not take during the first 14-day period (the total daily dose \[TDD\] remains approximately equivalent for the IR and ER forms throughout both double-blind periods); and a follow-up period. During the study, pain levels will be recorded and overall safety measures taken. The expectation (thought) is that approximately equivalent doses of both forms of tapentadol (CG5503) provide equivalent effectiveness and safety and that the two forms can be directly converted by dividing the total daily dose by the number of times the drug is taken each day. During the 21-day open-label period, 50, 75 or 100mg of the IR form is given orally every 4 or 6 hours, starting with 50mg every 6 hours. Then, the dose, the frequency of giving the drug, or both may be increased, to a maximum TDD of 500mg, or decreased in 50 mg increments, with minimum TDD of 200 mg, until the optimal stable dose for a patient is found. During the 2 double-blind periods, a TDD approximately equivalent to the stable open-label dose is given orally in IR (or ER) form or placebo.

Low Back Pain

Low Back Pain Dose Equivalence Tapentadol (CG5503) Tapentadol-IR Tapentadol-ER

null

2

arm 1: tapentadol (CG5503) Immediate Release (IR) Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100 150 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second,tapentadol (CG5503) Immediate Release IR 21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period arm 2: tapentadol (CG5503) Extended Release (ER) During 2 double blind periods: Tapentadol ER 100 150 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 21 day Open Label: an adjustable dose of Tapentadol IR 50-100mg orally every 4-6 hours to maximum total daily dose (TDD) dose of 500 mg during open label period intervention 2: During 2 double blind periods: Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in the first intervention period of double-blind phase and Tapentadol IR in the second or Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second intervention 3: Following open label period is 2 double blind periods: Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER 100, 150, 200 or 250 mg tablets twice daily in second or Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second

intervention 1: tapentadol (CG5503) Immediate Release IR intervention 2: tapentadol (CG5503) Extended Release (ER) intervention 3: tapentadol (CG5503) Immediate Release (IR)

0

null

0

NCT00594516

[ 3 ]

128

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).

null

Constipation

null

5

arm 1: Placebo arm 2: MOA-728 arm 3: MOA-728 arm 4: MOA-728 arm 5: MOA-728

[ 2, 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Oral Capsules intervention 2: Placebo

intervention 1: MOA-728 intervention 2: Placebo

0

null

0

NCT00605644

[ 3 ]

112

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia.

null

Chronic Primary Insomnia

insomnia elderly sleeplessness

null

10

arm 1: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 2: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 3: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 4: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 5: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 6: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 7: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 8: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 9: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo arm 10: 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]

10

[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: 5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo intervention 2: ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo intervention 3: ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo intervention 4: ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo intervention 5: ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo intervention 6: ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo intervention 7: ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo intervention 8: ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo intervention 9: ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo intervention 10: ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

intervention 1: ACT-078573 oral capsules at 25 and 100 mg and matching placebo intervention 2: ACT-078573 and matching placebo intervention 3: ACT-078573 and matching placebo intervention 4: ACT-078573 and matching placebo intervention 5: ACT-078573 and matching placebo intervention 6: ACT-078573 and matching placebo intervention 7: ACT-078573 and matching placebo intervention 8: ACT-078573 and matching placebo intervention 9: ACT-078573 and matching placebo intervention 10: ACT-078573 and matching placebo

21

0

NCT00606593

[ 0 ]

14

RANDOMIZED

PARALLEL

null

0NONE

true

1FEMALE

false

The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).

The investigators intend to conduct a prospective, randomized study at Oregon Health and Science University. This study will be conducted over six 28-day cycles. Subjects enrolled in the study will undergo baseline vaginal biopsy and then be randomized to receive either intravaginal ethinyl estradiol and etonogestrel (NuvaRing®) or oral ethinyl estradiol and desogestrel (Desogen®). Repeat vaginal biopsies will be obtained after three and six months of exposure to either oral or intravaginal hormonal contraception. These will be analyzed to measure the thickness of the vaginal epithelium and to quantify the presence of Langerhans cell, macrophages, T-lymphocytes and dendritic cells.

Contraceptive Usage Vaginal Epithelial Disruption

contraception NuvaRing Desogen vaginal biopsy

null

2

arm 1: Drug: ethinyl estradiol and desogestrel 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol; secen inactive pills every 28 days. Subjects receive baseline vaginal biopsy, followed by treatment with the OC for six cycles and repeat biopsy at 3 and after 6 cycles arm 2: Intravaginal Contraception ethinyl estradiol (0.15 mg/d) and etonogestrel (0.12 mg/d) Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring Subjects had baseline vaginal biopsy followed by 6 cycles of ring use and repeat biopsy at 3 and after 6 cycles

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol intervention 2: Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

intervention 1: Desogen (ethinyl estradiol and desogestrel) intervention 2: NuvaRing (ethinyl estradiol and etonogestrel)

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT00612508

[ 0 ]

80

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

1SINGLE

true

1FEMALE

true

The purpose of this study is to examine the effect of lidocaine (a numbing medication) inside the uterus on patient pain during an early abortion, compared to the paracervical block (lidocaine injected on either side of the cervix).

The Investigators intend to conduct a randomized, patient-blinded control trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette. Women will be approached about this study after they have made a decision to terminate the pregnancy. The women will be blinded and randomized into one of two study arms. Group 1: the investigator will apply pressure with the capped needle of the paracervical block at the cervical-vaginal reflexion at 4 and 8 o'clock. This will approximate the steps involved in a paracervical block without injecting the patient. Following this, the patient will receive a 5 milliliter intrauterine infusion of 4% lidocaine using a sterile 3mm Novak curette. The infusion will be placed slowly over 3 minutes. Group 2: a standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Following this, a 3 mm Novak curette will be placed in the vagina and held to the external os of the cervix for 3 minutes. The curette will not be placed through the cervix and no infusion will be performed. This will approximate the steps involved in an intrauterine infusion without injecting the patient. During the procedure, women in both groups will be asked to rate their pain at various times using a 10 cm visual analog scale (VAS).

Pain

surgical abortion pain management

null

2

arm 1: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. arm 2: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. intervention 2: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.

intervention 1: Lidocaine intervention 2: Lidocaine

2

0

NCT00613821

[ 4 ]

167

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized children. Hypothesis: Use of normal saline in 5% dextrose or reduced (2/3) volume of N/5 saline in 5% dextrose reduces incidence of hyponatremia (serum sodium 130 mmol/L) by two-thirds when compared to N/5 saline in 5% dextrose at standard maintenance rate in hospitalized children receiving intravenous maintenance fluids.

Hyponatraemia arises in between 20% and 45% of sick hospitalized children. An important reason for this high incidence could be use of hypotonic fluids in sick children for maintenance fluid therapy. There are no randomized controlled trials to evaluate the effect of various types of intravenous fluids on the incidence of hyponatremia in sick hospitalized children. We therefore plan to conduct a randomized controlled trial to evaluate the effect of normal saline in 5% dextrose at standard maintenance rate, reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose and N/5 saline in 5% dextrose at standard maintenance rate on the incidence of hyponatremia in hospitalized children, aged 3 months- 12 years. To determine serial plasma vasopressin levels in hospitalized children at baseline, 24 hours and 48 hours of intravenous fluid therapy and compare the values in the three fluid regimens. Study design: Randomized controlled trial. Hospitalized children who fulfill inclusion criteria and not having any of the exclusion criteria will be considered for the enrolment after written informed consent. Venous blood samples will be taken at enrollment for estimation of serum sodium, potassium, chloride, bicarbonate, blood gas, blood sugar, blood urea, serum creatinine, and plasma osmolality. A sample for estimation of plasma vasopressin will be collected at baseline. After randomization into three groups, one group of children will receive N/5 saline in 5% dextrose at standard maintenance rate (100 ml/kg for the first 10 kg of body weight, 50 ml/kg for the next 10 kg, and 20 ml/kg for body weight exceeding 20 kg).The second group of children will receive N/5 saline in 5% dextrose at 2/3 maintenance rate. The third group will receive dextrose normal saline at standard maintenance rate. Serum Na+, K+ and urine Na+, K+ will be estimated every 12 hourly till the patient is on intravenous fluid therapy and 12 hrs after stopping exclusive intravenous maintenance fluids. Serum and urine osmolality will be estimated every 24 hrs by an osmometer. Plasma vasopressin will be estimated in children in the 3 groups at 24, and 48 hours of intravenous fluid therapy. Children will be weighed every 24 hours. The fluid balance, sodium balance, free water clearance will be calculated in a subset of children. The study measurements will be carried out only till the time the child is on exclusive intravenous maintenance fluid therapy or 72 hrs of starting the intravenous fluid therapy. The decision to decrease/ stop intravenous fluid therapy will be left to the treating unit. The primary outcome measure will be incidence of hyponatremia (defined as serum Na+ less than 130 mmol/L). The secondary outcomes studied will be Plasma vasopressin levels at 24 hr and 48 hours and incidence of hypernatremia. Sample size: Based on literature review, the incidence of hyponatremia with standard intravenous fluid therapy is approximately 30%. Sample of 72 patients will be needed in each group to demonstrate the decrease in incidence of hyponatremia to 10%, with a beta of 0.2 (Power 80%) and alpha error of 0.05. Analysis: The data will be analyzed using STATA software. The outcomes (primary and secondary) in the 3 groups will be compared. For continuous variables, t test or Wilcoxon rank-sum test will be used to determine statistical significance. For categorical variables, chi square test will be used.

Hyponatremia

maintenance fluids hyponatremia vasopressin children

null

3

arm 1: Normal saline in 5% dextrose at standard maintenance rate arm 2: Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose arm 3: N/5 saline in 5% dextrose at standard maintenance rate

[ 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 0.9% saline with 5% dextrose at standard maintenance rate intervention 2: Reduced volume (two thirds of standard maintenance rate) of N/5 saline in 5% dextrose intervention 3: N/5 saline in 5% dextrose at standard maintenance rate

intervention 1: Isotonic fluid intervention 2: Hypotonic fluid intervention 3: Hypotonic fluid

1

New Delhi | National Capital Territory of Delhi | India | 77.2148 | 28.62137

0

NCT00621348

[ 4 ]

344

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients

This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.

Patients With Schizophrenia and Acute Agitation

schizophrenia, agitation, inhaled loxapine, ADASUVE

null

3

arm 1: Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours arm 2: Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours arm 3: Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Inhaled loxapine 5 mg intervention 2: Inhaled loxapine 10 mg intervention 3: Inhaled placebo

1

Atlanta | Georgia | United States | -84.38798 | 33.749

0

NCT00628589

[ 3 ]

3

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

We believe that hematopoietic stem cell transplantation (HSCT) will help subjects with Osteopetrosis generate functioning osteoclasts, and by so doing assist in the resolution of the abnormal bone architecture, and the anemia and bone marrow failure that is also characteristic of this disease. However, we have found in past studies that approximately 30% of Osteopetrosis patients do not engraft. Therefore, in this study, we plan to use a different combination of pre-transplant drugs to try to make transplants safer for this disease, as well as to provide a second infusion of stem cells in patients with matched related or unrelated donors. The purpose of this research is to find a safer and more effective means of performing stem cell transplantation in patients with Osteopetrosis, using chemotherapy and radiation designed to bring about engraftment and lessen transplant mortality.

This transplant protocol will test the following: 1) the ability to achieve engraftment with the reduced intensity protocol, 2) the mortality associated with transplant by day 100, 3) patient outcomes, based on differential imaging and biologic evaluations prior to transplantation and at designated points after transplantation (day 100, 6 months, 1, 2 and 5 years). Additional biologic studies will include microarray analysis, Campath levels just prior to the administration of the graft, and establishment of mesenchymal stem cell lines. In older patients, studies to evaluation osteoclast differentiation and function will also be offered.

Osteopetrosis

osteopetrosis

null

1

arm 1: Patients enrolled and received study treatment.

[ 0 ]

3

[ 3, 0, 3 ]

intervention 1: Stem Cell (unrelated or matched related donor grafts (both peripheral blood and marrow) infusion on Day 0 and 42; Umbilical Cord Blood on Day 0 and 42 intervention 2: * 12 Campath-1H 0.3 mg/kg intravenously (IV) over 2 hours * 11 Campath-1H 0.3 mg/kg intravenously over 2 hours * 10 Campath-1H 0.3 mg/kg intravenously over 2 hours * 9 Busulfan \<12 kg: 2.2 mg/kg/dose IV every 12 hours \>12 kg: 1.6 mg/kg/dose IV every 12 hours * 8 Busulfan \<12 kg: 2.2 mg/kg/dose IV every 12 hours \>12 kg: 1.6 mg/kg/dose IV every 12 hours * 7 "Rest" * 6 Clofarabine 40 mg/m2 intravenously over 2 hours * 5 Clofarabine 40 mg/m2 intravenously over 2 hours * 4 Clofarabine 40 mg/m2 intravenously over 2 hours * 3 Clofarabine 40 mg/m2 intravenously over 2 hours * 2 Clofarabine 40 mg/m2 intravenously over 2 hours intervention 3: Dose 500 cGy via anteroposterior (AP) and posteroanterior (PA) fields (250 cGy AP and 250 cGy PA).

intervention 1: Stem Cell or Umbilical Cord Blood Transplantation intervention 2: Campath, Busulfan, Clofarabine intervention 3: Total Lymphoid Irradiation

1

Minneapolis | Minnesota | United States | -93.26384 | 44.97997

0

NCT00638820

[ 2 ]

14

NON_RANDOMIZED

SINGLE_GROUP

4SUPPORTIVE_CARE

0NONE

true

0ALL

false

The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of dasatinib before and after 5 days of dosing with omeprazole in healthy subjects

null

Healthy

Healthy Subjects

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Tablet/Capsule, Oral, (Dasatinib 100 mg)/(Omeprazole 40 mg), once daily, 7 days

intervention 1: Dasatinib + Omeprazole

1

Hamilton | New Jersey | United States | -74.08125 | 40.20706

0

NCT00655746

[ 5 ]

20

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this research study is to see how often benzoyl peroxide is applied for acne. Use of medication was monitored electronically.

We give subjects topical benzoyl peroxide, a standard first line acne treatment, in a container that records when the container is opened and closed. Subjects will simply be asked to "return in six weeks to see how well benzoyl peroxide works for them." Subjects initially will not be told that they are participating in a formal study. When they return with their medication, we will seek their informed consent to participate in the study. Verbal consent will be obtained at the beginning of the study. There will be no written consent obtained until the end of the study. By doing this, subjects will not be aware that adherence is being measured. Subjects will not be aware that they are participating in a study. Only if they consent would we then collect the medication container and monitor and retrieve the adherence data. If they do not consent, we will not have collected any research data on them except baseline acne severity measures which may have been collected anyway as part of their clinic treatment.

Acne Vulgaris

null

1

arm 1: Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.

[ 0 ]

1

[ 0 ]

intervention 1: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.

intervention 1: Benzoyl Peroxide

1

Winston-Salem | North Carolina | United States | -80.24422 | 36.09986

0

NCT00658112

[ 3 ]

151

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

false

The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive Naproxen as control.

null

Pain

Analgesic effect Molar extraction

null

3

arm 1: AZD1940 800ug given predose arm 2: Naproxen 500mg given pre-surgery arm 3: Placebo given pre-surgery

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 800ug oral administration intervention 2: 500mg oral administration intervention 3: Placebo given pre-surgery

intervention 1: AZD1940 intervention 2: Naproxen intervention 3: Placebo

1

Salt Lake City | Utah | United States | -111.89105 | 40.76078

0

NCT00659490

[ 3, 4 ]

98

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).

Patients were treated with both Sulfamylon soaks and Silver nitrate soaks on different burn areas. These two areas were then compared for incidence (percentage) of infections.

Burn

Burn Wounds Wound infection Topical antimicrobials Cerium Dakins Sulfamylon Soaks Silver Nitrate

null

1

arm 1: Application of Sulfamylon 5% Solution and Silver Nitrate soaked dressings to two different burned area. Sites were then monitored for infections during hospitalization.

[ 0 ]

1

[ 0 ]

intervention 1: Application of Sulfamylon and Silver Nitrate Solution to burn wound daily

intervention 1: Sulfamylon 5% and Silver Nitrate Soaks

1

Galveston | Texas | United States | -94.7977 | 29.30135

0

NCT00675922

[ 5 ]

161

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.

This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound identified skin abscesses who were not on antibiotics. Patients were block randomized to receive placebo or trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3 days \& a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution with development of new lesion (furuncle, carbuncle or abscess) at a different location. Compliance was evaluated by the return of the study medication or by patient report.

Skin Diseases, Infectious

skin abscess CA-MRSA

null

2

arm 1: Maalox and bitter mixture arm 2: Trimethoprim-sulfamethoxazole suspension

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL. intervention 2: Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.

intervention 1: Trimethoprim-sulfamethoxazole intervention 2: Placebo group

1

St Louis | Missouri | United States | -90.19789 | 38.62727

0

NCT00679302

[ 4 ]

581

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine if two allergy medications are more effective than placebo.

null

Perennial Allergic Rhinitis

null

3

arm 1: Placebo arm 2: 0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks arm 3: 0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 0.15% azelastine hydrochloride 1644 mcg intervention 2: 0.1% azelastine hydrochloride 1096 mcg intervention 3: Placebo

intervention 1: 0.15% azelastine hydrochloride intervention 2: 0.1% azelastine hydrochloride intervention 3: Placebo

43

0

NCT00712920

[ 5 ]

12

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

true

0ALL

false

We have established that dietary protein is an important regulator of intestinal calcium absorption in humans. However, we do not understand the mechanism by which dietary protein is affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether dietary protein-induced changes in gastric acid secretion explain the observed changes in intestinal calcium absorption.

We have established that dietary protein is an important regulator of intestinal calcium absorption in humans. However, we do not understand the mechanism by which dietary protein is affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether dietary protein-induced changes in gastric acid secretion explain the observed changes in intestinal calcium absorption. We have compelling in vitro data that amino acids can stimulate gastric acid secretion. We have found that this occurs via allosteric activation of the calcium sensing receptor expressed on the gastric acid-secreting parietal cells. At a fixed concentration of extracellular calcium, addition of L but not D isomers of specific amino acids activates the calcium sensing receptor and stimulates parietal cell acid production. We hypothesize that dietary protein induced gastric acid production increases calcium solubility and bioavailability thereby increasing its absorption. We will test this hypothesis in humans by quantifying the impact of dietary protein on intestinal calcium absorption in subjects who cannot make gastric acid. We will measure intestinal calcium absorption in healthy adults as they consume either a high protein diet with concomitant administration of a proton pump inhibiting (PPI) drug or the same high protein diet with a placebo instead of a PPI. The order of the 2 interventions will be randomized, and study will be double-blind and placebo controlled. If our hypothesis is correct, then intestinal calcium absorption will be highest during the high protein diet with placebo, and lowest during the drug intervention.

Osteoporosis

Gastric acid Dietary protein Calcium Intestinal absorption Calcium sensing receptor

null

2

arm 1: None arm 2: None

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: 2 Interventions with esomeprazole 20 mg twice a day for 9 days vs. a placebo for 9 days while on a high protein diet intervention 2: Placebo 20 mg twice a day for 9 days

intervention 1: esomeprazole intervention 2: Placebo

1

New Haven | Connecticut | United States | -72.92816 | 41.30815

0

NCT00719160

[ 5 ]

30

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).

null

Angle-closure Glaucoma

IOP lowering efficacy CACG

null

2

arm 1: One drop in each eye, once daily at 9 AM arm 2: One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: One drop in each eye, once daily at 9 AM intervention 2: One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks

intervention 1: Travoprost 0.004% (Travatan) intervention 2: Pilocarpine 1%

0

null

0

NCT00762645

[ 3 ]

35

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those who are confirmed with their eligibility as subjects for the present study at the end of the baseline treatment period will be randomly allocated to one of the 6 treatment sequences on the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR tablet 40 mg and its placebo as follows (Double-blind treatment period).

Issues on safety are addressed in the Adverse Event section.

Hypertension

null

3

arm 1: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning arm 2: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening arm 3: Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning

[ 1, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning intervention 2: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening intervention 3: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning

intervention 1: Nifedipine (Adalat CR, BAYA1040) 80mg OD intervention 2: Nifedipine (Adalat CR, BAYA1040) 40mg BID intervention 3: Nifedipine (Adalat CR, BAYA1040) 40mg OD

3

0

NCT00768560

[ 5 ]

39

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.

This is a randomized, single-center controlled study comparing two different immunosuppression regimens (CsA and TAC) in patients with recurrent HCV after LT undergoing antiviral therapy for HCV.

Hepatitis C

Hepatitis C Post Liver Transplant

null

2

arm 1: Tacrolimus arm 2: Cyclosporine

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Patients randomized to CsA had TAC discontinued and were treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml. intervention 2: Patients receiving TAC were treated with a dose of 0.08-0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter. Immunosuppression was typically tapered to monotherapy (TAC alone) within 4-6 months of transplantation.

intervention 1: Cyclosporine intervention 2: Tacrolimus

0

null

0

NCT00821587

[ 2 ]

61

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.

null

Type 2 Diabetes Mellitus

null

2

arm 1: Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2. arm 2: Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.

[ 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods. intervention 2: Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods. intervention 3: Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.

intervention 1: Sitagliptin phosphate/metformin hydrochloride FDC intervention 2: Sitagliptin phosphate intervention 3: Metformin hydrochloride

0

null

0

NCT00929201

[ 3 ]

42

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This was a 52-week, multicentric, phase II, pilot study conducted in 40 subjects with early-onset Alzheimer's disease (AD) to evaluate safety, tolerability and clinical efficacy of subcutaneous (sc) interferon (IFN) beta-1a \[Rebif® 22 microgram (mcg), three times per week (tiw)\] in the treatment of AD by comparing the neuropsychological performance changes into placebo and treatment arms from screening/baseline to 52 week.

Alzheimer's disease is characterized by progressive cognitive impairment resulting from neuronal loss. The primary pathological feature of the disease is the extracellular deposition of fibrillary amyloid and its compaction into senile plaques. The senile plaque is the focus of a complex cellular reaction involving the activation of both microglia and astrocytes adjacent to the amyloid plaque. In fact, microglias are the most abundant and prominent cellular components associated with these plaques. Plaque-associated microglia exhibits a reactive or activated phenotype. Through the acquisition of a reactive phenotype, microglia responds to various stimuli, as is evident by the increased expression of numerous cell-surface molecules, including major histocompatibility complex (MHC) class-II antigens and complement receptors. Traditionally, multiple sclerosis (MS) has been considered a "demyelinating" disease. Recent immunocytochemical studies suggest that MS may be more than a demyelinating disorder, and that even in early stages of the disease, MS pathological scenario envisages axonal damage. Interferons, the modern therapeutic strategies for the treatment of MS, are cytokines - proteins which lead to a network of signals within different cells. In the immune system, IFNs act at different levels. For example, IFNs increase the expression of MHC class II antigens and, thereby, facilitate the antigen-presenting process and the activation of lymphocytes. T-lymphocytes are important targets of IFN immunomodulation. In MS, it is believed that IFN beta suppresses the production of proinflammatory cytokines such as IFN-γ and TNF-α, and increases the production of immunosuppressive cytokines such as interleukin-4 (IL-4) and IL-10. Since the activation of microglia and astrocytes is common to both AD and MS, IFN beta could have therapeutic applications in the treatment of AD. Furthermore, recent studies have also found that through astrocyte production, IFNs promote the activation of nerve-growth factor. OBJECTIVES * To evaluate safety, tolerability and clinical efficacy of IFN beta-1a (Rebif® 22 mcg, tiw) in the treatment of AD In this study, subjects were randomized into two groups: the first group (treatment arm, n=20) received Rebif® 22 mcg tiw; the second group (placebo arm, n=20) received placebo. The treatment period was for 28 weeks and subjects were followed up to Week 52. Efficacy was determined by comparing neuropsychological performance changes into placebo and treatment arms from screening/baseline to Week 52. On Day 1 of the study treatment period, subjects received injection training and were administered the first dose of Rebif under the supervision of the clinical personnel by subcutaneous injection tiw at approximately the same time each day preferably in the late afternoon or evening. All subjects received 28 weeks of therapy and after 24 weeks from the therapy conclusion, a termination visit was conducted.

Alzheimer's Disease

Alzheimer's Dementia Interferon beta-1a Rebif

null

2

arm 1: Subjets in this arm received interferon beta-1a (Rebif® 22 mcg tiw) arm 2: Subjects in this arm received placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Interferon (IFN) beta-1a \[Rebif® 22 microgram (mcg), three times per week (tiw)\] administered subcutaneously (sc) intervention 2: The inactive substance (placebo) looks the same as Interferon beta-1a (Rebif®), and is given the same way

intervention 1: Interferon beta-1a intervention 2: Placebo

1

Catania | CT | Italy | 15.07041 | 37.49223

0

NCT01075763

[ 4 ]

199

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

true

The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm after electrical conversion in patients with persistent Atrial fibrillation (AF).

Atrial fibrillation (AF) is the most common sustained arrhythmia and represents an increasing burden on the healthcare system. Treatment of AF remains controversial. In patients on antiarrhythmic therapy, the one-year relapse rates of AF after cardioversion ranges from 44% to 77% at one year and amiodarone appears to the be the most effective in maintaining sinus rhythm.Over the last few years, a growing amount of evidences has supported the protective effects of n-3 PUFAs in preventing ventricular arrhythmias and reducing the risk of sudden cardiac death. Furthermore, in the last years, the interest for their possible beneficial role in AF prevention has been increasing.We hypothesized that the administration of n-3 PUFAs could reduce the AF recurrence rate more than amiodarone plus RAAS inhibitors in patients with persistent AF. Therefore the present study aims to evaluate the role of n-3 PUFAs in the prophylaxis of AF recurrences after DCCV in addition to amiodarone and RAS blockers therapy in patients with persistent AF.

Atrial Fibrillation

PUFA atrial fibrillation

null

2

arm 1: None arm 2: None

[ 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 1.0 g of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in the average ratio EPA/DHA of 0.19:1.5, one capsule twice a day intervention 2: 1.0 g of olive oil,one capsule twice a day intervention 3: Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, an ACE-I or an ARB was started. In all patients, an effort was made to achieve the highest tolerated dose. intervention 4: Patients on amiodarone were continued at a maintenance dose of 200 mg daily, whereas those who were not taking amiodarone were started at a dose of 400 mg daily for 1 week and then continued on a maintenance dose of 200 mg daily.

intervention 1: n-3 PUFAs intervention 2: Placebo intervention 3: RASS inhibitors and/or RAS blockers intervention 4: Amiodarone

1

Brescia | Brescia | Italy | 10.21472 | 45.53558

0

NCT01198275

[ 0 ]

152

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

1FEMALE

true

The purpose of this study is to test a behavioral intervention to minimize sleep disruption and fatigue in new mothers after the birth of their first infant. This study also tests whether an acetaminophen intervention at the time of an infant's 2-month immunization series improves infant and maternal sleep.

null

Pregnancy Postpartum Period Sleep Disturbance

sleep hygiene actigraphy maternal infant postpartum period immunization acetaminophen

null

3

arm 1: Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance. Infants in this arm receive no intervention beyond standard immunization care. arm 2: Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep. Infants in this arm receive standard immunization care. arm 3: Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep. Infants in this arm receive an acetaminophen intervention (12.5mg per kg infant weight, 1 dose 30 minutes prior to immunization and q4-6h thereafter, for a total of 5 doses) to minimize sleep disturbance following immunization.

[ 1, 0, 0 ]

3

[ 5, 5, 0 ]

intervention 1: This intervention consists of behavioral strategies for minimizing maternal arousal and sleep disturbance as a result of night-time infant care. Key components include: infant proximity, low lighting, and noise attenuation. It is administered to women during their last month of pregnancy. intervention 2: This intervention consists of dietary information aimed at improving postpartum sleep. The recommendations include avoiding alcohol, caffeine, and heavy meals before bed, as well as eating healthy foods. intervention 3: 51-90mg depending on infant weight (12.5mg per kg infant weight). Administered 30 minutes prior to immunization and q4-6h for a total of 5 doses.

intervention 1: Sleep hygiene intervention 2: Dietary information intervention 3: Acetaminophen

1

San Francisco | California | United States | -122.41942 | 37.77493

0

NCT01321710

[ 5 ]

178

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in the treatment of aspirin-related ulcers. Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40 mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up endoscopy was carried out at the end of the eighth week. The primary end point was the healing of peptic ulcers.

Peptic Ulcer

aspirin peptic ulcer

null

2

arm 1: esomeprazole (40 mg/day) for 8 weeks arm 2: esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks

[ 4, 1 ]

1

[ 0 ]

intervention 1: aspirin, 100 mg, qd x 8 weeks

intervention 1: aspirin

3

0

NCT01353144

[ 2 ]

20

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This was an open-label PK study in pediatric subjects who had undergone general surgery. Each subject's study participation consisted of a screening visit, a single-dose treatment with intranasal ketorolac (IN) tromethamine, and a follow-up visit. Following surgery, subjects received IN ketorolac 15 mg (weight \< 50 kg) or 30 mg (weight \> or = 50 kg) when pain relief was indicated. For pain not relieved by the study drug, the subjects had access to an opioid analgesic administered by patient-controlled analgesia (PCA). Blood samples for pharmacokinetic analysis were obtained at specified time points following the dose of ketorolac.

null

Postoperative Pain

null

2

arm 1: Ketorolac Tromethamine - single dose (15 mg) administered intranasally (IN) for subjects weighing \<50 kg. arm 2: Ketorolac Tromethamine - single dose (30 mg) administered intranasally (IN) for subjects weighing ≥50 kg.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Single IN dose of 15 mg ketorolac tromethamine for subjects weighing \<50 kg. intervention 2: Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.

intervention 1: Ketorolac Tromethamine intervention 2: Ketorolac Tromethamine

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT01363076

[ 5 ]

473

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to another medication) in Filipino participants with chronic (lasting a long time) osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).

This is an open-label (all people know the identity of the intervention), randomized (study drug assigned by chance), controlled study to evaluate the efficacy, safety and effects on QOL of tramadol/APAP as an add-on therapy in Filipino participants suffering from chronic pain because of chronic osteoarthritis. Participants will be randomly assigned to 2 groups: tramadol/APAP group and non tramadol/APAP group. Participants in tramadol/APAP group will receive celecoxib 200 milligram (mg) and fixed dose combination of tramadol (37.5 mg)/APAP (325 mg) as add on therapy, while the participants in non-tramadol/APAP group will receive celecoxib 200 mg only. The total duration of the study will be 4 weeks. The participants in both the groups will be given celecoxib 200 mg once daily for 4 weeks. In addition, the participants in the tramadol/APAP group will be given add-on tramadol/APAP doses 3 times a day for 4 weeks. Participants will be asked to return for follow-up at Weeks 2 and 4. Efficacy will be assessed using 100 millimeter (mm) Visual Analog Scale (VAS) while QOL will be assessed using the Oswestry Disability Index (ODI). Participant safety will be monitored throughout the study.

Osteoarthritis

Osteoarthritis Celecoxib Tramadol Paracetamol

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Celecoxib 200 milligram (mg) once daily for 4 weeks and fixed dose combination of Tramadol 37.5 mg/Paracetamol 325 mg thrice daily for 4 weeks as add-on therapy. intervention 2: Celecoxib 200 mg alone once daily for 4 weeks.

intervention 1: Tramadol/Paracetamol (APAP) intervention 2: Non-Tramadol/APAP

1

Paranaque City | National Capital Region | Philippines | 121.01749 | 14.48156

0

NCT01728246

[ 5 ]

1,059

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to the bones) outpatient or emergency setting.

This is an open-label (all people know the identity of the intervention), non-randomized, multi-center (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) study of tramadol hydrochloride-paracetamol tablets. Participants will receive 1 to 2 tablets of tramadol hydrochloride-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \[mg\] and paracetamol 325mg). Participants may be given the additional dose according to the clinical requirement. The total treatment duration will be 6 hours. The total study duration will be 4 months. Efficacy will be evaluated primarily by pain intensity and pain relief. Participants will evaluate the pain severity and pain relief at 0.5, 1, 2, 3, 4 and 6 hours respectively after the first dose; and the drug efficacy and overall satisfaction level at the end of 6 hours after the first dose. Participants' safety will be monitored throughout the study.

Low Back Pain Shoulder Pain Neck Pain

Low back pain Shoulder pain Neck pain Tramadol hydrochloride Paracetamol

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Participants will receive 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \[mg\] and paracetamol 325mg) for up to a total duration of 6 hours. Additional dose may be given based upon the clinical requirement.

intervention 1: Tramadol HCl-Paracetamol

0

null

0

NCT01843660

[ 5 ]

10

NON_RANDOMIZED

SINGLE_GROUP

2DIAGNOSTIC

3TRIPLE

true

1FEMALE

false

The purpose of the study is to establish that sustained estrogen levels are the driving force for the LH surge, and are thereby necessary for ovulation to occur. We predict that by reducing levels of circulating estrogen, letrozole, an aromatase inhibitor, will inhibit ovulation from occurring.

Sine the common understanding of ovulation in a natural cycle suggests that a sustained, elevated estradiol level is required to trigger the LH surge, administration of letrozole throughout the cycle should lower estradiol levels and prevent the LH surge from occurring. In this study, we sought to determine if the LH surge, ovulation and luteinization occurs in spite of low estradiol levels by daily administration of letrozole in a group of normal ovulatory volunteers in a prospective study. After IRB approval and informed consent were obtained, ten willing volunteers that met inclusion criteria (no hormonal contraception within 3 months, regular menstrual cycles 26 - 30 days, normal thyroid function and normal prolactin, and no pregnancy currently or within 3 months) were monitored for one month without treatment for evaluation of normal ovulation. Natural control cycle The subjects used home urine LH tests (Clearblue® Easy, SPD Swiss Precision Diagnostics, Switzerland) on days 10-18 to monitor for the LH surge in both the initial natural cycle and the letrozole cycle. Blood was drawn every other day starting on day 12 of the cycle through day 22 to measure estradiol and progesterone levels, and follicular development was monitored using transvaginal ultrasound on cycle day 12-14. Letrozole cycle In the next cycle, all ten subjects were administered oral letrozole 5 mg daily (Femara®, Novartis Pharmaceuticals Corporation, East Hanover, NJ ) starting on cycle day 1-3 and continuing through the completion of the study (cycle day 22). Once again, serum estradiol and progesterone levels were measured every other day on days 12-22. The development of the ovarian follicles was monitored by transvaginal ultrasound once in each cycle between days 12-14, and LH surge was monitored with home urine ovulation tests on days 10-18. Table 1 illustrates protocols for both the natural control cycle and the letrozole study cycle. The primary outcome, assessment of ovulation in letrozole cycles, was determined by the presence or absence of progesterone elevation (\>1.5 ng/mL) and the presence or absence of a positive urinary LH test. The bioequivalence evaluation of two cycles (before and after letrozole administration) was based on pharmacokinetic parameters such as area under the serum concentration-time curve (AUC), the peak serum concentration (Cmax) and the time of peak serum concentration (Tmax). Cmax and Tmax were determined by visual inspection from each volunteer's serum concentration-time curve for estradiol and progesterone. AUC was calculated by the linear trapezoidal method from day 12 through day 22 in both the initial natural cycle and the letrozole cycle. Paired t-tests, or Wilcoxon Signed Rank tests if non-normally distributed, were used to evaluate the statistical significance of the mean values of the pharmacokinetic parameters. The McNemar test was used to assess the difference in LH surge and follicular development before and after letrozole administration. A standard of statistical significance (alpha) of 0.05 was used in all cases. The SAS System (SAS Institute, Cary, NC) was used for all analyses.

Ovulation Disorder Ovarian Cysts

null

2

arm 1: Control cycle. No intervention. arm 2: 5mg daily

[ 4, 0 ]

1

[ 0 ]

intervention 1: Letrozole administered daily through the time of ovulation.

intervention 1: Letrozole

1

Charlotte | North Carolina | United States | -80.84313 | 35.22709

0

NCT01999569

[ 3 ]

10

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study evaluated the efficacy and safety of Avastin (bevacizumab, 5 mg/kg intravenously every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines of prior therapy.

null

Multiple Myeloma

null

1

arm 1: Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.

[ 0 ]

1

[ 0 ]

intervention 1: Bevacizumab was provided as a concentrate in vials.

intervention 1: Bevacizumab

4

Salzburg | N/A | Austria | 13.04399 | 47.79941 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849

0

NCT02079519

[ 3 ]

11

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This research study is for people who have previously received cancer vaccines. The investigators are testing a form of therapy known as interferon alfa-2a, which is commercially available as the drug Roferon®-A, to see if it can be used to help boost the effects of the cancer vaccine and help the immune system attack the cancer. It is believed that the body's immune system can attack tumor cells and kill them. This is thought to be due to immune cells called T cells which can recognize special proteins on the surface of tumors as a signal to fight the cancer. However, the vaccine may not work very well if the protein signal is too weak for the T cells to find your tumors. The investigators think that interferon alfa-2a can signal the cancer cells in the body to make more proteins that may allow the T cells to recognize and kill the cancer cells better.

null

Cancer

null

1

arm 1: Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Interferon Alfa-2a

0

null

0

NCT02159482

[ 5 ]

180

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This randomized, multi-center, Phase IV, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).

null

Hepatitis C, Chronic

null

2

arm 1: Participants will receive Peg-IFN-Alpha-2A and ribavirin for 48 weeks. arm 2: Participants will receive Peg-IFN-Alpha-2A and ribavirin for 72 weeks.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Peg-IFN-Alpha-2A will be administered at 180 micrograms (mcg) once weekly via subcutaneous injection. intervention 2: Ribavirin will be administered as either 1000 milligrams (mg) (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing less than (\<) 75 kilograms (kg) or as 1200 mg (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing greater than or equal to (\>/=) 75 kg.

intervention 1: Peg-Interferon Alpha-2A intervention 2: Ribavirin

17

Campinas | N/A | Brazil | -47.06083 | -22.90556 Florianópolis | N/A | Brazil | -48.54917 | -27.59667 Itajaí | N/A | Brazil | -48.66194 | -26.90778 Juiz de Fora | N/A | Brazil | -43.35028 | -21.76417 Porto Alegre | N/A | Brazil | -51.23019 | -30.03283 Recife | N/A | Brazil | -34.88111 | -8.05389 Ribeirão Preto | N/A | Brazil | -47.81028 | -21.1775 Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 Rio Grande | N/A | Brazil | -52.09861 | -32.035 Santo André | N/A | Brazil | -46.53833 | -23.66389 Santos | N/A | Brazil | -46.33361 | -23.96083 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475

0

NCT02761629

[ 5 ]

2

RANDOMIZED

SINGLE_GROUP

4SUPPORTIVE_CARE

2DOUBLE

false

1FEMALE

false

RATIONALE: L-carnitine L-tartrate may prevent peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized clinical trial is studying how well L-carnitine L-tartrate works in preventing peripheral neuropathy caused by chemotherapy in women with metastatic breast cancer.

OBJECTIVES: * To evaluate the tolerability and usefulness of the dietary supplement, L-carnitine L-tartrate, in the prevention of chemotherapy-induced peripheral neuropathy in women with metastatic breast cancer. OUTLINE: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. * Arm II: Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. Patients complete questionnaires periodically to assess neuropathy, pain, fatigue, sleep, and activities of daily living. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Breast Cancer Chemotherapeutic Agent Toxicity Neurotoxicity

neurotoxicity chemotherapeutic agent toxicity stage IV breast cancer recurrent breast cancer

null

2

arm 1: Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. arm 2: Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: Given orally intervention 2: Given orally

intervention 1: L-carnitine L-tartrate intervention 2: placebo

2

0

NCT00754767

[ 3 ]

4

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

false

Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) and how migalastat works in participants with Fabry disease.

This was a Phase 2, open-label study in male participants with Fabry disease. The study consisted of a 4-week screening period during which participants' genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat via an in vitro assay. Participants were required to have α-Gal A activity responsive to migalastat. The study consisted of a 12-week treatment period, followed by an optional 36-week extension period. Participants received migalastat 150 milligrams (mg) once every other day (QOD) for 12 weeks during the treatment period. Participants could then opt to participate in the extension period.

Fabry Disease

Amicus Therapeutics AT1001 Galafold Migalastat Substrate

null

1

arm 1: Migalastat 150 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week extension period.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: migalastat HCl

2

Parkville | N/A | Australia | 144.95 | -37.78333 Porto Alegre | N/A | Brazil | -51.23019 | -30.03283

0

NCT00283959

[ 3 ]

9

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

true

Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.

This was a Phase 2, open-label study in female participants with Fabry disease. The study consisted of a 4-week screening period, during which participants' galactosidase (GLA) genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat. Participants were required to have α-Gal A activity responsive to migalastat. The study consisted of a 12-week treatment period, followed by an optional 36-week extension period. Participants received migalastat once every other day (QOD) for 12 weeks during the treatment period and the optional 36-week extension period for a total treatment duration of up to 48 weeks. Participants were stratified by α-Gal A enzyme activity (high \>40%, and low ≤40%) then randomly assigned to receive migalastat at 1 of 3 specified dose levels (50, 150, or 250 milligrams \[mg\]).

Fabry Disease

Amicus Therapeutics AT1001 Galafold Migalastat Substrate

null

3

arm 1: Migalastat 50 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period. arm 2: Migalastat 150 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period. arm 3: Migalastat 250 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: migalastat HCl

6

Decatur | Georgia | United States | -84.29631 | 33.77483 Parkville | Victoria | Australia | 144.95 | -37.78333 Porto Alegre | N/A | Brazil | -51.23019 | -30.03283 Montreal | N/A | Canada | -73.58781 | 45.50884 Paris | N/A | France | 2.3488 | 48.85341 Salford | N/A | United Kingdom | -2.29042 | 53.48771

0

NCT00304512

[ 3 ]

8

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286) regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone (recFSH) can induce monofollicular growth (one follicle ≥18 mm and no other follicle ≥15 mm at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.

This trial will include two separate stages (Ia+Ib and II). Stage Ia will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose recFSH provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria. Stage Ib will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose hCG provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria. Stage II is open-label and randomized (n=40) to evaluate whether the intended dosing regimen of corifollitropin alfa followed by low dose FSH (n=20) or hCG (n=20) provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

Ovulation Induction

Pharmacological effects of drugs Hormones Hormone Substitutes and Hormone Antagonists Pharmacological Actions Monofollicular growth Randomized Open-label Active-controlled

null

2

arm 1: Eligible participants will receive a subcutaneous (SC) injection of corifollitropin alfa (Stage 1a: 15mcg, Stage Ib/II: 30 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient, the participant will receive a second or third dose of corifollitropin alfa (Stage 1a: 15 mcg, Stage Ib/II: 20 mcg). As soon as the largest follicle reaches a size of ≥12 mm, the participant will start daily SC injections with FSH (Stage 1A: 50 IU, Stage II: 75 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is ≥18 mm and in total no more than two follicles ≥15 mm are observed. arm 2: Eligible participants will receive a SC injection of corifollitropin alfa (Stage Ia:15 mcg, Stage Ib/II: 30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient the participant will receive a second or third dose of corifollitropin alfa (Stage IA: 15 mcg, stage Ib/II: 20 mcg). As soon as the largest follicle reaches a size of ≥12 mm the participant will start daily SC injections with hCG (Stage Ib/II: 200 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is ≥18 mm and in total no more than two follicles ≥15 mm are observed.

[ 0, 0 ]

4

[ 0, 2, 2, 2 ]

intervention 1: SC corifollitropin alfa on the 1st, 2nd or 3rd day after onset of a progestagen-induced withdrawal bleeding (Stage 1a: 15mcg, Stage Ib/II: 30 mcg). intervention 2: Daily injections of SC recFSH (50 IU/75 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13. intervention 3: Daily injections of SC hCG (200 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13. intervention 4: Bolus injection of SC hCG was administered to induce final oocyte maturation if at least one follicle is ≥18 mm and no more than two follicles ≥15 mm are observed.

intervention 1: corifollitropin alfa intervention 2: recombinant Follicle Stimulating Hormone (recFSH) intervention 3: human Chorion Gonadotropin (hCG) intervention 4: hCG Bolus injection

0

null

0

NCT00697255

[ 4 ]

94

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator-controlled, parallel-group study in participants with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. The total duration of a participant's participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Participants who complete the randomized portion of the study per protocol may have the opportunity to continue in a long-term extension study of active treatments.

null

Type 2 Diabetes Mellitus

null

8

arm 1: rivoglitazone HCl 0.5mg arm 2: rivoglitazone HCl 1.0 mg arm 3: rivoglitazone HCl 1.5 mg arm 4: placebo matching rivoglitazone HCl tablets arm 5: pioglitazone HCl 15 mg arm 6: pioglitazone HCl 30 mg arm 7: pioglitazone HCl 45 mg arm 8: matching placebo for pioglitazone

[ 0, 0, 0, 2, 1, 1, 1, 2 ]

9

[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: 0.5 mg tablets administered orally, once daily intervention 2: 1.0 mg tablets administered orally, once daily intervention 3: 1.5 mg tablets administered orally, once daily intervention 4: placebo tablets matching rivoglitazone tablets administered orally, once daily intervention 5: 15 mg capsules administered orally, once daily intervention 6: 30 mg capsules administered orally, once daily intervention 7: 45 mg capsules administered orally, once daily intervention 8: placebo capsules for pioglitazone administered orally, once daily intervention 9: Oral tablets. Rescue medication.

intervention 1: Rivoglitazone HCl intervention 2: rivoglitazone HCl intervention 3: rivoglitazone HCl intervention 4: placebo intervention 5: pioglitazone HCl intervention 6: pioglitazone HCl intervention 7: pioglitazone HCl 45 mg intervention 8: placebo intervention 9: metformin

18

0

NCT00571519

[ 5 ]

90

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will test whether spironolactone, an approved drug for among other things hypertension, will reduce the risk of severe arrhythmias in patients with implanted defibrillators. Half the patients in the study will get spironolactone and half will get a placebo. Neither the patients or their providers will know if they are getting spironolactone or placebo.

Objectives: This study is designed to determine whether spironolactone at a dose of 25 mg per day in patients with implanted cardioverter defibrillators (ICD) will 1) Reduce the incidence of ventricular tachycardia (VT) and ventricular fibrillation (VF), 2) Improve health related quality of life, 3) Reduce the need for hospitalization, and 4) Change ventricular refractoriness. Plan: The study was a randomized double blind placebo controlled multi-center trial. Patients were randomized to either 25 mg per day of spironolactone or placebo and followed for 2 years each. The primary endpoint is time to the first episode of VT/VF. Secondary endpoints will include changes in health related quality of life, frequency of hospitalization, and in a subset of patients the effect of spironolactone on the ventricular effective refractory period measured through the ICD 3 months after starting the study medication. All data analyses will be conducted on intent to treat basis. Methods: Patients were recruited at the Portland VA ICD clinics, the Seattle VA ICD clinics, Oregon Health and Sciences University ICD clinics and the Little Rock, Arkansas VA ICD clinics. Randomization and drug preparation were done by the Portland VA Medical Center research pharmacy. For safety purposes serum potassium will be measured at 1, 2, 3, 6, 12, 18, and 24 months. Patients will undergo ICD interrogation to document the occurrence of ICD therapy for VT or VF and will be screened for potential drug side effects every 3 months during the study. Health related quality of life will be measured at baseline, 3, 6, 12, 18, and 24 months using Short Form Health Survey adapted for veterans (SF36V) Veterans Health Study Version, the Patients Concerns Assessment, and the Kansas City Cardiomyopathy Questionnaire. Hospitalizations will be tracked throughout the study. In the subset of patient enrolled at the Portland VA the ventricular effective refractory period will be measured via single extra stimuli pacing through the ICD at 3 months after randomization.

Ventricular Arrhythmias

Anti-Arrhythmia Agents Ventricular Fibrillation Ventricular Tachycardia Defibrillators, Implantable

null

2

arm 1: Patients randomized to active therapy with spironolactone arm 2: patients randomized to placebo

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: aldosterone blocker intervention 2: identical in appearance to spironolactone study drug

intervention 1: spironolactone intervention 2: placebo

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT04495712

[ 4 ]

1,791

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.

Primary Hypothesis: Intensive glycemic control reduces major macrovascular morbidity and mortality compared to standard glycemic control in type 2 diabetics who have failed simple therapy. Secondary Hypotheses: Intensive glycemic control, compared to standard glycemic control, reduces other macrovascular morbidity and total mortality. Intervention: The intervention is tight glycemic control, aiming at normalization of HbA1c. This will be achieved through stepped care therapy, using all categories of tools available to most diabetologists. These categories include: patient education of diabetes control (e.g. diet, exercise, etc.), oral diabetes medications, and insulin. All drugs to be used are approved. Specific agents will be used within the different classes to promote consistency across sites. The comparison is standard control, aiming at HbA1c of 8 - 9%. The same agents will be used, but at reduced doses. The general approach to the stepped care treatment protocol is to treat both groups with the same agents, but at different intensities (doses) (taking into account intolerance/contraindications). The sequence of steps is shown below. STEP 1: Either Metformin (obese) or Glimepiride (lean)in combination with Rosiglitazone STEP 2: Insulin STEP 3: Increase doses in STEPS 1,2 in the Standard group. Since the Intensive group is already at maximal doses of oral agents, they will intensify insulin and may add Acarbose/Miglitol. STEP 4: For standard, proceed as in STEP 3 for Intensive; Intensives will use multiple daily injection (MDI) of insulin STEP 5: "Tool Box": Miscellaneous agents, tailored to the individual patient. Primary Outcomes: Time to one of the following major macrovascular events: myocardial infarction, stroke, new or worsening congestive heart failure, amputation for ischemic gangrene, invasive intervention for coronary artery or peripheral vascular disease, inoperable coronary artery disease, or cardiovascular death. Secondary Outcomes: Angina, transient ischemic attack, intermittent claudication, critical limb ischemia, and total mortality. Study Abstract: A quarter of the patients treated by the Department of Veterans Affairs (VA) Health Administration have type 2 diabetes mellitus (DM). The costs of care for the treatment of patients with type 2 DM are extremely high, both in treatment expenditures for the metabolic disorder and for the care of end-organ complications. Although patients initially respond to diet and oral agent treatment, most eventually need insulin to near-normalize their glucose level, as the disease is characterized by progressive loss of insulin secretory capacity. After several clinical trials in both type 1 and type 2 DM, there is a reasonable certainty that about half of the incidence and rate of progression of indicators of microvascular complications (retinopathy, nephropathy, and neuropathy) can be prevented or delayed by achieving and maintaining near-normalization of glycemic levels. Consequently, there has been a uniform trend in recent guidelines to advise a near-normalization of glycemic levels in both type 1 and type 2 DM. Note, however, that the clinical consequences of microvascular deterioration are dependent not only on glycemic levels but also on the duration of the disease. With the early onset of diabetes typical in type 1 patients, there is sufficient time for development of clinical microvascular complications, and prevention of these complications is a goal of treatment in type 1 diabetics. In contrast, the prevalence of hard clinical endpoints indicative of microangiopathy, such as renal failure or blindness, is very low in patients in whom the disease is diagnosed after the 5th decade, the greatest age of prevalence of patients with type 2 DM in this country. Furthermore, microvascular complications can be minimized by the well-established benefits of blood pressure and lipid control, as well as by therapeutic intervention (photocoagulation, cataract extraction). Since the costs and efforts necessary to reach near-normal levels of glycemia are very high, there is a need to determine the cost/benefit ratios of such expenditures in the population subject to type 2 diabetes, namely patients in their 6th to 8th decades of life. In contrast with the late and relatively infrequent appearance of clinical endpoints of microangiopathy, macrovascular complications (i.e., coronary heart disease and peripheral vascular disease) are responsible for the overwhelming majority of the mortality, morbidity and treatment costs in the American population of type 2 diabetics, even more so in the older VA diabetic population. In the recently concluded United Kingdom Prospective Diabetes Study (UKPDS) on type 2 DM, macrovascular mortality was 70 times higher than that of microvascular mortality. Intervention studies to determine the effect of rigorous glycemic control on these macrovascular events are inconclusive and contradictory. Intensive treatment in patients who are newly diagnosed has failed to demonstrate a beneficial effect of tight control on cardiovascular complications. The few studies conducted in later stages of the disease (i.e., in patients requiring insulin treatment, alone or in combination with oral agents) have been conflicting and indeterminate. The decision on intensity of treatment is further compromised by current recommendations to attenuate glycemic control goals, especially when usage of insulin is required, both in patients with the common comorbidities of overweight or preexisting cardiovascular disease, and in those in the later decades of life. These concerns are based on fears that intensive insulin treatment might be associated with weight gain, increased cardiovascular risk factors (hypertriglyceridemia, dyslipidemia, hyperinsulinemia, and insulin resistance), and adverse effects of recurrent hypoglycemic events. The prevalent level of glycemic control in insulin-treated type 2 diabetics is relatively poor, likely due to a combination of practical difficulties and the uncertainties of what are the safe and effective glycemic goals. There is no long-term study currently being done in the high-risk population typical of the patient population in the VA. Before the Department of Veterans Affairs devotes considerable resources to a widespread intervention (a quarter of patients) that may be of little value, and might even be counterproductive, a trial to determine the value of the intervention is mandated. It is expected that CSP #465 will provide the scientific data on which the VA can base clinical treatment of Type II diabetes. CSP #465 is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 25% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications. Main Manuscript:Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N et al., VADT investigators: Glucose Control and Complications in the VA Diabetes Trial (VADT). N Eng J of Med 360:129-139, 2009.

Type 2 Diabetes Mellitus

DM glycemic control insulin type 2 diabetes mellitus

null

2

arm 1: Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs arm 2: Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1

[ 1, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs Arm 1 Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs, add one injection of insulin Arm 2 intervention 2: Glimepiride 2 mg Arm 1 Glimepiride 8 mg Arm 2 intervention 3: Rosiglitazone 4 mg Arm 1 Rosiglitazone 4 mg bid Arm 2 intervention 4: Metformin 500 mg (go up to 1000 mg) Arm 1 Metformin 500 mg (go up to 2000 mg) Arm

intervention 1: Insulin intervention 2: Glimepiride intervention 3: Rosiglitazone intervention 4: Metformin

21

0

NCT00032487

[ 4 ]

259

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.

Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience hallucinations,and, more commonly delusions, in addition to major depression. Psychotic experiences may be either congruent with the theme of depression or incongruent, without an apparent relationship to feeling depressed. This study will determine the effectiveness of combining a selective serotonin reuptake inhibitor (SSRI) with antipsychotic medication in the treatment of psychotic depression accompanied by at least one identifiable delusion. The study will also evaluate the difference in treatment response of young adults versus geriatric patients. This double-blind study will last a total of 12 weeks. Participants will be randomly assigned to receive either olanzapine, an atypical antipsychotic drug, combined with sertraline, an SSRI, or olanzapine alone. Following baseline assessments, study visits will occur weekly until Week 6, and then bi-weekly until Week 12. Participants who do not respond to either treatment may leave the study at any time. Participants who achieve either partial or full response may participate in an additional 20-week study.

Major Depressive Disorder With Psychotic Features

Major depressive disorder with psychotic features Delusional Depression Randomized Trial Combination Treatment SSRI Atypical Antipsychotic

null

2

arm 1: sertraline plus olanzapine arm 2: olanzapine (5 - 20mg/day) plus placebo

[ 1, 2 ]

3

[ 0, 0, 10 ]

intervention 1: 10-20mg/day intervention 2: 150-200mg/day intervention 3: tablet that ressembles sertraline but contains no medication

intervention 1: Olanzapine intervention 2: Sertraline intervention 3: placebo

4

1

NCT00056472

[ 5 ]

31,546

null

PARALLEL

1PREVENTION

null

false

0ALL

null

The Ongoing Telmisartan Alone and in combination wiht Ramipril Global Endpoint trial (ONTARGET): The primary objectives are to determine if (a) telmisartan 80mg daily and ramipril 10mg daily combination therapy is more effective in reducing the composite endpoint of Cardiovascular Death (CV) death, Myocardial infarction (MI), stroke or hospitalization for Congestive Heart Failure (CHF) compared with ramipril 10mg alone; and (b) telmisartan 80mg daily is at least as effective as (i.e. not less effective than) ramipril 10mg daily, on this endpoint. Telmisartan Randomised Assessment Study in Angiotension converting Enzyme inhibitor intolerant subjects with Cardiovascular Disease. (TRANSCEND): The primary objective of the study is to determine if treatment with telmisartan 80mg daily is superior to placebo reducing the composite endpoint of Cardiovascular Death (CV), Myocardial Infarction ( MI)I, stroke or hospitalization for Congestive Heart Failure (CHF) in patients who are intolerant to Angiotension Converting Enzyme inhibitors.

null

Cardiovascular Diseases

null

0

null

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Telmisartan intervention 2: Combination of Telmisartan and Ramipril intervention 3: Ramipril

732

Athens | Alabama | United States | -86.97219 | 34.80243 Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Tuscon | Arizona | United States | N/A | N/A Bentonville | Arkansas | United States | -94.20882 | 36.37285 Concord | California | United States | -122.03107 | 37.97798 Harbor City | California | United States | -118.29785 | 33.79002 Loma Linda | California | United States | -117.26115 | 34.04835 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | California | United States | -121.4944 | 38.58157 San Diego | California | United States | -117.16472 | 32.71571 San Leandro | California | United States | -122.15608 | 37.72493 Sylmar | California | United States | -118.44925 | 34.30778 West Hills | California | United States | -118.64398 | 34.19731 Bridgeport | Connecticut | United States | -73.18945 | 41.17923 Farmington | Connecticut | United States | -72.83204 | 41.71982 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Gainesville | Florida | United States | -82.32483 | 29.65163 Palm Harbor | Florida | United States | -82.76371 | 28.07807 Panama City | Florida | United States | -85.65983 | 30.15946 Tampa | Florida | United States | -82.45843 | 27.94752 Vero Beach | Florida | United States | -80.39727 | 27.63864 Weston | Florida | United States | -80.39977 | 26.10037 Augusta | Georgia | United States | -81.97484 | 33.47097 Augusta | Georgia | United States | -81.97484 | 33.47097 Augusta | Georgia | United States | -81.97484 | 33.47097 Conyers | Georgia | United States | -84.01769 | 33.66761 Sandersville | Georgia | United States | -82.81014 | 32.98154 Savannah | Georgia | United States | -81.09983 | 32.08354 Tucker | Georgia | United States | -84.21714 | 33.85455 Valdosta | Georgia | United States | -83.28032 | 30.83334 Pocatello | Idaho | United States | -112.44553 | 42.8713 Burbank | Illinois | United States | -87.7795 | 41.73392 Chicago | Illinois | United States | -87.65005 | 41.85003 Olympia Fields | Illinois | United States | -87.67421 | 41.51337 Des Moines | Iowa | United States | -93.60911 | 41.60054 Monroe | Louisiana | United States | -92.1193 | 32.50931 Shreveport | Louisiana | United States | -93.75018 | 32.52515 Baltimore | Maryland | United States | -76.61219 | 39.29038 Boston | Massachusetts | United States | -71.05977 | 42.35843 Springfield | Massachusetts | United States | -72.58981 | 42.10148 Wyandotte | Michigan | United States | -83.14992 | 42.21421 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Saint Paul | Minnesota | United States | -93.09327 | 44.94441 Biloxi | Mississippi | United States | -88.88531 | 30.39603 Cleveland | Mississippi | United States | -90.72482 | 33.744 Jackson | Mississippi | United States | -90.18481 | 32.29876 Kansas City | Missouri | United States | -94.57857 | 39.09973 St Louis | Missouri | United States | -90.19789 | 38.62727 St Louis | Missouri | United States | -90.19789 | 38.62727 Omaha | Nebraska | United States | -95.94043 | 41.25626 North Las Vegas | Nevada | United States | -115.1175 | 36.19886 Camden | New Jersey | United States | -75.11962 | 39.92595 East Orange | New Jersey | United States | -74.20487 | 40.76732 Newark | New Jersey | United States | -74.17237 | 40.73566 Westwood | New Jersey | United States | -74.03264 | 40.99121 Brooklyn | New York | United States | -73.94958 | 40.6501 Buffalo | New York | United States | -78.87837 | 42.88645 Kingston | New York | United States | -73.99736 | 41.92704 New York | New York | United States | -74.00597 | 40.71427 New York | New York | United States | -74.00597 | 40.71427 New York | New York | United States | -74.00597 | 40.71427 Northport | New York | United States | -73.34317 | 40.90093 Rochester | New York | United States | -77.61556 | 43.15478 Rochester | New York | United States | -77.61556 | 43.15478 Scarsdale | New York | United States | -73.78458 | 41.0051 The Bronx | New York | United States | -73.86641 | 40.84985 Westfield | New York | United States | -79.5781 | 42.32228 Williamsville | New York | United States | -78.73781 | 42.96395 Durham | North Carolina | United States | -78.89862 | 35.99403 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Fargo | North Dakota | United States | -96.7898 | 46.87719 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Cleveland | Ohio | United States | -81.69541 | 41.4995 Dayton | Ohio | United States | -84.19161 | 39.75895 Mansfield | Ohio | United States | -82.51545 | 40.75839 Oklahoma City | Ohio | United States | N/A | N/A Guthrie | Oklahoma | United States | -97.42532 | 35.87894 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Tulsa | Oklahoma | United States | -95.99277 | 36.15398 Portland | Oregon | United States | -122.67621 | 45.52345 Erie | Pennsylvania | United States | -80.08506 | 42.12922 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Sellersville | Pennsylvania | United States | -75.3049 | 40.35399 Charleston | South Carolina | United States | -79.93275 | 32.77632 Columbia | South Carolina | United States | -81.03481 | 34.00071 Dallas | Texas | United States | -96.80667 | 32.78306 Dallas | Texas | United States | -96.80667 | 32.78306 Dallas | Texas | United States | -96.80667 | 32.78306 Dallas | Texas | United States | -96.80667 | 32.78306 Fort Worth | Texas | United States | -97.32085 | 32.72541 Houston | Texas | United States | -95.36327 | 29.76328 Houston | Texas | United States | -95.36327 | 29.76328 Houston | Texas | United States | -95.36327 | 29.76328 Burke | Virginia | United States | -77.27165 | 38.79345 Seattle | Washington | United States | -122.33207 | 47.60621 Milwaukee | Wisconsin | United States | -87.90647 | 43.0389 Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Corones Suárez | N/A | Argentina | N/A | N/A Córdoba | N/A | Argentina | -64.18853 | -31.40648 Córdoba | N/A | Argentina | -64.18853 | -31.40648 Córdoba | N/A | Argentina | -64.18853 | -31.40648 Córdoba | N/A | Argentina | -64.18853 | -31.40648 Córdoba | N/A | Argentina | -64.18853 | -31.40648 La Plata | N/A | Argentina | -57.95442 | -34.92126 Mar del Plata | N/A | Argentina | -57.5562 | -38.00042 Mendoza | N/A | Argentina | -68.84582 | -32.88946 Mendoza | N/A | Argentina | -68.84582 | -32.88946 Rosario | N/A | Argentina | -60.63932 | -32.94682 Salta | N/A | Argentina | -65.41999 | -24.80645 San Miguel de Tucumán | N/A | Argentina | -65.21051 | -26.81601 San Miguel de Tucumán | N/A | Argentina | -65.21051 | -26.81601 Santa Fe | N/A | Argentina | -60.70868 | -31.64881 Zárate | N/A | Argentina | -59.02423 | -34.09584 Woden | Australian Capital Territory | Australia | N/A | N/A Camperdown | New South Wales | Australia | 151.17642 | -33.88965 Coffs Harbour | New South Wales | Australia | 153.11351 | -30.29626 Concord | New South Wales | Australia | 151.10381 | -33.84722 Gosford | New South Wales | Australia | 151.34399 | -33.4244 Gosford | New South Wales | Australia | 151.34399 | -33.4244 Kogarah | New South Wales | Australia | 151.13564 | -33.9681 Kogarah | New South Wales | Australia | 151.13564 | -33.9681 Kogarah | New South Wales | Australia | 151.13564 | -33.9681 Newcastle | New South Wales | Australia | 151.7801 | -32.92953 Randwick | New South Wales | Australia | 151.24895 | -33.91439 St Leonards | New South Wales | Australia | 151.19836 | -33.82344 Wollongong | New South Wales | Australia | 150.89345 | -34.424 Chermside | Queensland | Australia | 153.03062 | -27.38472 Herston | Queensland | Australia | 153.01852 | -27.44453 Kippa-Ring | Queensland | Australia | 153.0835 | -27.22586 Southport | Queensland | Australia | 153.39796 | -27.96724 Woolloongabba | Queensland | Australia | 153.03655 | -27.48855 Bedford Park | South Australia | Australia | 138.56815 | -35.02204 Daw Park | South Australia | Australia | 138.58407 | -34.98975 Port Lincoln | South Australia | Australia | 135.87442 | -34.72625 Launceston | Tasmania | Australia | 147.13467 | -41.43876 Box Hill | Victoria | Australia | 145.12545 | -37.81887 Epping | Victoria | Australia | 145.03333 | -37.65 Geelong | Victoria | Australia | 144.36069 | -38.14711 Parkville | Victoria | Australia | 144.95 | -37.78333 Prahran | Victoria | Australia | 144.99318 | -37.85114 Prahran | Victoria | Australia | 144.99318 | -37.85114 Ringwood East | Victoria | Australia | 145.25 | -37.81667 West Heidelberg | Victoria | Australia | N/A | N/A Fremantle | Western Australia | Australia | 115.74557 | -32.05632 Nedlands | Western Australia | Australia | 115.8073 | -31.98184 Perth | Western Australia | Australia | 115.8614 | -31.95224 Graz | N/A | Austria | 15.45 | 47.06667 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Wels | N/A | Austria | 14.03333 | 48.16667 Aalst | N/A | Belgium | 4.0355 | 50.93604 Anderlecht | N/A | Belgium | 4.31454 | 50.83619 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Bornem | N/A | Belgium | 4.24364 | 51.09716 Brasschaat | N/A | Belgium | 4.49182 | 51.2912 Bruges | N/A | Belgium | 3.22424 | 51.20892 Charleroi | N/A | Belgium | 4.44448 | 50.41136 Genk | N/A | Belgium | 5.50082 | 50.965 Godinne | N/A | Belgium | 4.87364 | 50.34809 Haine-Saint-Paul | N/A | Belgium | 4.1885 | 50.45544 Haine-Saint-Paul | N/A | Belgium | 4.1885 | 50.45544 Hasselt | N/A | Belgium | 5.33781 | 50.93106 Leuven | N/A | Belgium | 4.70093 | 50.87959 Mechelen | N/A | Belgium | 4.47762 | 51.02574 Mol | N/A | Belgium | 5.11662 | 51.19188 Roeselare | N/A | Belgium | 3.12269 | 50.94653 Seraing | N/A | Belgium | 5.50115 | 50.58362 Turnhout | N/A | Belgium | 4.94471 | 51.32254 Turnhout | N/A | Belgium | 4.94471 | 51.32254 Woluwé-Saint-Lambert | N/A | Belgium | N/A | N/A Belo Horizonte | N/A | Brazil | -43.93778 | -19.92083 Belo Horizonte | N/A | Brazil | -43.93778 | -19.92083 Belo Horizonte | N/A | Brazil | -43.93778 | -19.92083 Botucatu | N/A | Brazil | -48.445 | -22.88583 Campinas | N/A | Brazil | -47.06083 | -22.90556 Campinas | N/A | Brazil | -47.06083 | -22.90556 Cerqueira César - São Paulo | N/A | Brazil | N/A | N/A Curitiba | N/A | Brazil | -49.27306 | -25.42778 Goiânia | N/A | Brazil | -49.25389 | -16.67861 Marília | N/A | Brazil | -49.94583 | -22.21389 Pelotas | N/A | Brazil | -52.34101 | -31.76997 Porto Alegre | N/A | Brazil | -51.23019 | -30.03283 Porto Alegre | N/A | Brazil | -51.23019 | -30.03283 Porto Alegre - Rs | N/A | Brazil | N/A | N/A Ribeirão Preto | N/A | Brazil | -47.81028 | -21.1775 Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 Rio de Janeiro - Rj | N/A | Brazil | N/A | N/A Salvador | N/A | Brazil | -38.49096 | -12.97563 Salvador | N/A | Brazil | -38.49096 | -12.97563 Santa Catalina | N/A | Brazil | N/A | N/A São José do Rio Preto | N/A | Brazil | -49.37944 | -20.81972 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Vila Clementino, São Paulo | N/A | Brazil | N/A | N/A Calgary | Alberta | Canada | -114.08529 | 51.05011 Calgary | Alberta | Canada | -114.08529 | 51.05011 Edmonton | Alberta | Canada | -113.46871 | 53.55014 Campbell River | British Columbia | Canada | -125.24459 | 50.01634 Coquitlam | British Columbia | Canada | -122.78217 | 49.2846 Kelowna | British Columbia | Canada | -119.48568 | 49.88307 New Westminster | British Columbia | Canada | -122.91092 | 49.20678 North Vancouver | British Columbia | Canada | -123.06934 | 49.31636 Penticton | British Columbia | Canada | -119.58584 | 49.48062 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Victoria | British Columbia | Canada | -123.35155 | 48.4359 Manitoba | Manitoba | Canada | N/A | N/A Saint Pierre | Manitoba | Canada | N/A | N/A Winnipeg | Manitoba | Canada | -97.14704 | 49.8844 St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494 St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494 Antigonish | Nova Scotia | Canada | -61.99858 | 45.61685 Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 Brampton | Ontario | Canada | -79.76633 | 43.68341 Greater Sudbury | Ontario | Canada | -80.99001 | 46.49 Hamilton | Ontario | Canada | -79.84963 | 43.25011 Hamilton | Ontario | Canada | -79.84963 | 43.25011 Hamilton | Ontario | Canada | -79.84963 | 43.25011 Hamilton | Ontario | Canada | -79.84963 | 43.25011 Hamilton | Ontario | Canada | -79.84963 | 43.25011 Hamilton | Ontario | Canada | -79.84963 | 43.25011 London | Ontario | Canada | -81.23304 | 42.98339 Mississauga | Ontario | Canada | -79.6583 | 43.5789 New Westminster | Ontario | Canada | N/A | N/A Newmarket | Ontario | Canada | -79.46631 | 44.05011 Niagara Falls | Ontario | Canada | -79.06627 | 43.10012 Orléans | Ontario | Canada | -75.50433 | 45.45732 Oshawa | Ontario | Canada | -78.84957 | 43.90012 Oshawa | Ontario | Canada | -78.84957 | 43.90012 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Rexdale | Ontario | Canada | -79.57106 | 43.72087 Sault Ste. Marie | Ontario | Canada | -84.33325 | 46.51677 Scarborough Village | Ontario | Canada | -79.22124 | 43.73899 Thunder Bay | Ontario | Canada | -89.25018 | 48.38202 Toronto | Ontario | Canada | -79.39864 | 43.70643 Toronto | Ontario | Canada | -79.39864 | 43.70643 Willowdale | Ontario | Canada | -79.39909 | 43.76672 Windsor | Ontario | Canada | -83.01654 | 42.30008 Fleurimont | Quebec | Canada | -71.83796 | 45.40842 Gatineau | Quebec | Canada | -75.70164 | 45.47723 Laval | Quebec | Canada | -73.692 | 45.56995 Lévis | Quebec | Canada | -71.17793 | 46.80326 Longueuil | Quebec | Canada | -73.46818 | 45.5152 Longueuil | Quebec | Canada | -73.46818 | 45.5152 Longueuil | Quebec | Canada | -73.46818 | 45.5152 Longueuil | Quebec | Canada | -73.46818 | 45.5152 Longueuil | Quebec | Canada | -73.46818 | 45.5152 Longueuil | Quebec | Canada | -73.46818 | 45.5152 Longueuil | Quebec | Canada | -73.46818 | 45.5152 Montreal | Quebec | Canada | -73.58781 | 45.50884 Montreal | Quebec | Canada | -73.58781 | 45.50884 Montreal | Quebec | Canada | -73.58781 | 45.50884 Montreal | Quebec | Canada | -73.58781 | 45.50884 Montreal | Quebec | Canada | -73.58781 | 45.50884 Québec | Quebec | Canada | -71.21454 | 46.81228 Québec | Quebec | Canada | -71.21454 | 46.81228 Québec | Quebec | Canada | -71.21454 | 46.81228 Québec | Quebec | Canada | -71.21454 | 46.81228 Saint George de Beauce | Quebec | Canada | N/A | N/A Ste-Foy | Quebec | Canada | N/A | N/A Terrebonne | Quebec | Canada | -73.64732 | 45.70004 Thetford-Mines | Quebec | Canada | -71.30539 | 46.09371 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Changsha | N/A | China | 112.97087 | 28.19874 Chengdu | N/A | China | 104.06667 | 30.66667 Chengdu | N/A | China | 104.06667 | 30.66667 Guangzhou | N/A | China | 113.25 | 23.11667 Harbin | N/A | China | 126.65 | 45.75 HeBei Province | N/A | China | N/A | N/A Henan Province | N/A | China | N/A | N/A Hubei Province | N/A | China | N/A | N/A Nanjing | N/A | China | 118.77778 | 32.06167 Qingdao | N/A | China | 120.38042 | 36.06488 ShanDong Province | N/A | China | N/A | N/A ShanDong Province | N/A | China | N/A | N/A Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 Shenyang | N/A | China | 123.43278 | 41.79222 Shijiazhuang | N/A | China | 114.47861 | 38.04139 Tianjin | N/A | China | 117.17667 | 39.14222 Tianjin | N/A | China | 117.17667 | 39.14222 Weizikeng | N/A | China | 116.60218 | 26.6475 Wuhan | N/A | China | 114.26667 | 30.58333 Zhenzhou | N/A | China | 119.16999 | 32.28034 Brno | N/A | Czechia | 16.60796 | 49.19522 Havířov | N/A | Czechia | 18.43688 | 49.77984 Kladno | N/A | Czechia | 14.10285 | 50.14734 Mladá Boleslav | N/A | Czechia | 14.90318 | 50.41135 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Příbram | N/A | Czechia | 14.01043 | 49.68988 Ústí nad Orlicí | N/A | Czechia | 16.39361 | 49.97387 Aalborg | N/A | Denmark | 9.9187 | 57.048 Aarhus C | N/A | Denmark | 10.21231 | 56.16558 Elsinore | N/A | Denmark | 12.6136 | 56.03606 Frederiksberg | N/A | Denmark | 12.53463 | 55.67938 Frederiksberg C | N/A | Denmark | N/A | N/A Hilleroed | N/A | Denmark | N/A | N/A Holbæk | N/A | Denmark | 11.71279 | 55.7175 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Kjellerup | N/A | Denmark | 9.43528 | 56.28581 Randers | N/A | Denmark | 10.03639 | 56.4607 Slagelse | N/A | Denmark | 11.35459 | 55.40276 Svendborg | N/A | Denmark | 10.60677 | 55.05982 Hämeenlinna | N/A | Finland | 24.46434 | 60.99596 Helsinki | N/A | Finland | 24.93545 | 60.16952 Helsinki | N/A | Finland | 24.93545 | 60.16952 Jyväskylä | N/A | Finland | 25.72088 | 62.24147 Kuopio | N/A | Finland | 27.67703 | 62.89238 Kuusankoski | N/A | Finland | 26.62437 | 60.907 Liperi | N/A | Finland | 29.36667 | 62.53333 Oulun Kaupunki | N/A | Finland | N/A | N/A Turku | N/A | Finland | 22.26869 | 60.45148 Vantaa | N/A | Finland | 25.04099 | 60.29414 Albens | N/A | France | 5.94528 | 45.78786 Béziers | N/A | France | 3.21402 | 43.34122 Bourges | N/A | France | 2.4 | 47.08333 Broglie | N/A | France | 0.52915 | 49.00911 Castelnaudary | N/A | France | 1.95339 | 43.31814 Gémenos | N/A | France | 5.62843 | 43.29751 Husseren Wesserlin | N/A | France | N/A | N/A Hyères | N/A | France | 6.12857 | 43.12038 L'Aigle | N/A | France | 0.62746 | 48.76216 La Rochelle | N/A | France | -1.15222 | 46.16308 Le Pradet | N/A | France | 6.0235 | 43.10545 Mûrs-Erigné | N/A | France | -0.55293 | 47.39592 Nantes | N/A | France | -1.55336 | 47.21725 Nantes | N/A | France | -1.55336 | 47.21725 Niort | N/A | France | -0.45877 | 46.32313 Orthez | N/A | France | -0.77266 | 43.48834 Paris | N/A | France | 2.3488 | 48.85341 Rennes | N/A | France | -1.67429 | 48.11198 Rosiers-d'Égletons | N/A | France | 2.00813 | 45.37738 Saint Martin dHyeres | N/A | France | N/A | N/A Saint-Julien-des-Landes | N/A | France | -1.71425 | 46.64058 Saint-Pierre-de-Chandieu | N/A | France | 5.01481 | 45.64625 Saint-Romain-sur-Cher | N/A | France | 1.39956 | 47.31877 Strasbourg | N/A | France | 7.74553 | 48.58392 Tours | N/A | France | 0.70398 | 47.39484 Bad Lausick | N/A | Germany | 12.64449 | 51.14495 Bad Lauterberg im Harz | N/A | Germany | 10.47031 | 51.63272 Bad Mergentheim | N/A | Germany | 9.77361 | 49.4925 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Bielefeld | N/A | Germany | 8.53333 | 52.03333 Cologne | N/A | Germany | 6.95 | 50.93333 Dessau | N/A | Germany | 12.24555 | 51.83864 Dortmund | N/A | Germany | 7.466 | 51.51494 Dortmund | N/A | Germany | 7.466 | 51.51494 Dresden | N/A | Germany | 13.73832 | 51.05089 Eberswalde | N/A | Germany | 13.81951 | 52.83492 Erlangen | N/A | Germany | 11.00783 | 49.59099 Essen | N/A | Germany | 7.01228 | 51.45657 Haag | N/A | Germany | 12.07614 | 50.30379 Hamburg | N/A | Germany | 9.99302 | 53.55073 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Homburg/Saar | N/A | Germany | N/A | N/A Karlsburg | N/A | Germany | 13.61007 | 53.97172 Kelkheim | N/A | Germany | 8.4502 | 50.13703 Künzing | N/A | Germany | 13.08333 | 48.66667 Lübeck | N/A | Germany | 10.68729 | 53.86893 Mainz | N/A | Germany | 8.2791 | 49.98419 Melsungen | N/A | Germany | 9.55236 | 51.13029 München | N/A | Germany | 13.31243 | 51.60698 Offenbach | N/A | Germany | 8.76647 | 50.10061 Riesa | N/A | Germany | 13.29168 | 51.30777 Rostock | N/A | Germany | 12.14049 | 54.0887 Sindelfingen | N/A | Germany | 9.01667 | 48.7 Starnberg | N/A | Germany | 11.34416 | 48.00193 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Timmendorfer Strand | N/A | Germany | 10.77676 | 53.9953 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 Witten | N/A | Germany | 7.35258 | 51.44362 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Corinth | N/A | Greece | 22.9513 | 37.94007 Elefsina | N/A | Greece | 23.54295 | 38.04135 Goudi/ Athens | N/A | Greece | N/A | N/A Ioannina | N/A | Greece | 20.85189 | 39.66486 Kavala,greece | N/A | Greece | 24.40687 | 40.93959 Melissia, Athens | N/A | Greece | N/A | N/A Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Véria | N/A | Greece | 22.55173 | 37.19027 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Kecskemét | N/A | Hungary | 19.69128 | 46.90618 Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539 Pécs | N/A | Hungary | 18.23083 | 46.0725 Siófok | N/A | Hungary | 18.058 | 46.90413 Szeged | N/A | Hungary | 20.14824 | 46.253 Székesfehérvár | N/A | Hungary | 18.41034 | 47.18995 Tatabánya | N/A | Hungary | 18.39325 | 47.58494 Veszprém | N/A | Hungary | 17.91149 | 47.09327 Dublin | N/A | Ireland | -6.24889 | 53.33306 Dublin | N/A | Ireland | -6.24889 | 53.33306 Dublin | N/A | Ireland | -6.24889 | 53.33306 Mallow | N/A | Ireland | -8.63333 | 52.13333 Ascoli Piceno | N/A | Italy | 13.57395 | 42.85351 Bentivoglio (BO) | N/A | Italy | 11.41737 | 44.6369 Bologna | N/A | Italy | 11.33875 | 44.49381 Bologna | N/A | Italy | 11.33875 | 44.49381 Brescia | N/A | Italy | 10.21472 | 45.53558 Casarano (LE) | N/A | Italy | 18.16237 | 40.01131 Caserta | N/A | Italy | 14.33231 | 41.07262 Città Della Pieve (PG) | N/A | Italy | 12.00696 | 42.95934 Ferrara | N/A | Italy | 11.62057 | 44.83804 Monfalcone (go) | N/A | Italy | 13.53292 | 45.80463 Napoli | N/A | Italy | 14.5195 | 40.87618 Napoli | N/A | Italy | 14.5195 | 40.87618 Napoli | N/A | Italy | 14.5195 | 40.87618 Napoli | N/A | Italy | 14.5195 | 40.87618 Palermo | N/A | Italy | 13.3636 | 38.1166 Pavia | N/A | Italy | 9.15917 | 45.19205 Perugia | N/A | Italy | 12.38878 | 43.1122 Perugia | N/A | Italy | 12.38878 | 43.1122 Perugia | N/A | Italy | 12.38878 | 43.1122 Pozzilli (IS) | N/A | Italy | 14.06252 | 41.51142 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 S. Pietro Vernotico (BR) | N/A | Italy | N/A | N/A Sassari | N/A | Italy | 8.55552 | 40.72586 Torino | N/A | Italy | 11.99138 | 44.88856 Varese | N/A | Italy | 8.82511 | 45.82058 Venezia | N/A | Italy | 11.17365 | 44.42329 Viterbo | N/A | Italy | 12.1056 | 42.41937 George Town | N/A | Malaysia | 100.33543 | 5.41123 Johor Bahru | N/A | Malaysia | 103.7578 | 1.4655 Kelantan Darul Naim | N/A | Malaysia | N/A | N/A Kelantan | N/A | Malaysia | N/A | N/A Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Kuala Selangor | N/A | Malaysia | 101.25 | 3.35 Putrajaya | N/A | Malaysia | 101.69112 | 2.93527 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Mexico | N/A | Mexico | -98.43784 | 18.88011 Mexico | N/A | Mexico | -98.43784 | 18.88011 Monterrey | N/A | Mexico | -100.31721 | 25.68435 Zapopan | N/A | Mexico | -103.38742 | 20.72111 Zapopan | N/A | Mexico | -103.38742 | 20.72111 's-Hertogenbosch | N/A | Netherlands | 5.30417 | 51.69917 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Beverwijk | N/A | Netherlands | 4.65694 | 52.48333 Doetinchem | N/A | Netherlands | 6.28889 | 51.965 Drachten | N/A | Netherlands | 6.0989 | 53.11254 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Ermelo | N/A | Netherlands | 5.62222 | 52.29833 Ewijk | N/A | Netherlands | 5.7375 | 51.87 Hengelo | N/A | Netherlands | 6.79306 | 52.26583 Hoorn | N/A | Netherlands | 5.05972 | 52.6425 Huizen | N/A | Netherlands | 5.24167 | 52.29917 Lichtenvoorde | N/A | Netherlands | 6.56667 | 51.98667 Losser | N/A | Netherlands | 7.00417 | 52.26083 Nieuwegein | N/A | Netherlands | 5.08056 | 52.02917 Rijswijk | N/A | Netherlands | 4.32501 | 52.03634 Roelofarendsveen | N/A | Netherlands | 4.63333 | 52.20333 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Spijkenisse | N/A | Netherlands | 4.32917 | 51.845 Stadskanaal | N/A | Netherlands | 6.9504 | 52.98947 The Hague | N/A | Netherlands | 4.29861 | 52.07667 Tilburg | N/A | Netherlands | 5.0913 | 51.55551 Utrecht | N/A | Netherlands | 5.12222 | 52.09083 Velp | N/A | Netherlands | 5.97361 | 51.995 Auckland | N/A | New Zealand | 174.76349 | -36.84853 Auckland | N/A | New Zealand | 174.76349 | -36.84853 Christchurch | N/A | New Zealand | 172.63333 | -43.53333 Hamiton | N/A | New Zealand | N/A | N/A Hasting | N/A | New Zealand | N/A | N/A Otahuhu Auckland | N/A | New Zealand | N/A | N/A Takapuna Auckland | N/A | New Zealand | N/A | N/A Tauranga | N/A | New Zealand | 176.16667 | -37.68611 Fevik | N/A | Norway | 8.67601 | 58.3782 Nesttun | N/A | Norway | 5.35317 | 60.31821 Stavanger | N/A | Norway | 5.73332 | 58.97005 Tvedestrand | N/A | Norway | 8.93147 | 58.62203 Tønsberg | N/A | Norway | 10.40762 | 59.26754 Cavite | N/A | Philippines | 120.76978 | 15.67785 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Pasig | N/A | Philippines | 121.0614 | 14.58691 Quezon City | N/A | Philippines | 121.0509 | 14.6488 Quezon City | N/A | Philippines | 121.0509 | 14.6488 Bydgoszcz | N/A | Poland | 18.00762 | 53.1235 Częstochowa | N/A | Poland | 19.12409 | 50.79646 Gdynia | N/A | Poland | 18.53188 | 54.51889 Gdynia Redlowo | N/A | Poland | N/A | N/A Grójec | N/A | Poland | 20.86757 | 51.86252 Grudziądz | N/A | Poland | 18.75366 | 53.48411 Inowrocław | N/A | Poland | 18.26387 | 52.79886 Jarosławiec | N/A | Poland | 23.69983 | 50.90785 Katowice | N/A | Poland | 19.02754 | 50.25841 Katowice | N/A | Poland | 19.02754 | 50.25841 Kielce | N/A | Poland | 20.62752 | 50.87033 Lodz | N/A | Poland | 19.47395 | 51.77058 Lubartów | N/A | Poland | 22.60952 | 51.46026 Lubin | N/A | Poland | 16.20149 | 51.40089 Nowy Sącz | N/A | Poland | 20.69705 | 49.62177 Piotrkow Trybunalski | N/A | Poland | 19.70321 | 51.40547 Poznan | N/A | Poland | 16.92993 | 52.40692 Ruda Śląska | N/A | Poland | 18.85632 | 50.2584 Skierniewice | N/A | Poland | 20.15837 | 51.95485 Tarnów | N/A | Poland | 20.98698 | 50.01381 Tomaszów Mazowiecki | N/A | Poland | 20.00855 | 51.53131 Torun | N/A | Poland | 18.59814 | 53.01375 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Węgrów | N/A | Poland | 22.01634 | 52.39954 Almada | N/A | Portugal | -9.1569 | 38.67902 Amadora | N/A | Portugal | -9.23083 | 38.75382 Carnaxide | N/A | Portugal | -9.24671 | 38.72706 Coimbra | N/A | Portugal | -8.41955 | 40.20564 Faro | N/A | Portugal | -7.92716 | 37.01869 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Matosinhos Municipality | N/A | Portugal | -8.68908 | 41.18207 Porto | N/A | Portugal | -8.61099 | 41.14961 Vila Nova de Gaia | N/A | Portugal | -8.61241 | 41.12401 Caguas | N/A | Puerto Rico | -66.0485 | 18.23412 Las Lomas | N/A | Puerto Rico | -66.50989 | 18.06191 Manatí | N/A | Puerto Rico | -66.49212 | 18.42745 Orocovis | N/A | Puerto Rico | -66.391 | 18.2269 Rio Piedras | N/A | Puerto Rico | -66.04989 | 18.39745 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Kuala Lumpur | N/A | Singapore | N/A | N/A Singapore | N/A | Singapore | 103.85007 | 1.28967 Singapore | N/A | Singapore | 103.85007 | 1.28967 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Košice | N/A | Slovakia | 21.25808 | 48.71395 Košice | N/A | Slovakia | 21.25808 | 48.71395 Nitra | N/A | Slovakia | 18.08453 | 48.30763 Rimavská Sobota | N/A | Slovakia | 20.02239 | 48.38284 Bellville | N/A | South Africa | 18.62847 | -33.90022 Bloemfontein | N/A | South Africa | 26.214 | -29.12107 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Durban | N/A | South Africa | 31.0292 | -29.8579 Fiachrdtpark, Bloemfontein | N/A | South Africa | 26.214 | -29.12107 George East | N/A | South Africa | N/A | N/A KwaKhangela | N/A | South Africa | 30.99535 | -29.87931 Park Town West | N/A | South Africa | N/A | N/A Port Elizabeth | N/A | South Africa | 25.61494 | -33.96109 Port Elizabeth | N/A | South Africa | 25.61494 | -33.96109 Soweto | N/A | South Africa | 27.85849 | -26.26781 Sunninghill | N/A | South Africa | 28.06552 | -26.0355 Sunninghill | N/A | South Africa | 28.06552 | -26.0355 Vanderbijlpark | N/A | South Africa | 27.83795 | -26.71171 Incheon | N/A | South Korea | 126.70515 | 37.45646 Kwangju | N/A | South Korea | 127.1279 | 36.9122 Pusan | N/A | South Korea | 128.3681 | 36.3809 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Taegu | N/A | South Korea | 128.07278 | 34.88889 Alcorcón (Madrid) | N/A | Spain | -3.82487 | 40.34582 Alicante | N/A | Spain | -0.48149 | 38.34517 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Burjasot (Valencia) | N/A | Spain | N/A | N/A Granada | N/A | Spain | -3.60667 | 37.18817 Granada | N/A | Spain | -3.60667 | 37.18817 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Málaga | N/A | Spain | -4.42034 | 36.72016 Málaga | N/A | Spain | -4.42034 | 36.72016 Murcia | N/A | Spain | -1.13004 | 37.98704 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Seville | N/A | Spain | -5.97317 | 37.38283 Valencia | N/A | Spain | -0.37966 | 39.47391 Valencia | N/A | Spain | -0.37966 | 39.47391 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Helsingborg | N/A | Sweden | 12.69437 | 56.04673 Järfälla | N/A | Sweden | N/A | N/A Malmo | N/A | Sweden | 13.00073 | 55.60587 Malmo | N/A | Sweden | 13.00073 | 55.60587 Malmo | N/A | Sweden | 13.00073 | 55.60587 Malmo | N/A | Sweden | 13.00073 | 55.60587 Sjuntorp | N/A | Sweden | 12.21667 | 58.2 Trollhättan | N/A | Sweden | 12.28864 | 58.28365 Vännäs | N/A | Sweden | 19.75712 | 63.90676 Basel | N/A | Switzerland | 7.57327 | 47.55839 Bellinzona | N/A | Switzerland | 9.01703 | 46.19278 Bern | N/A | Switzerland | 7.44744 | 46.94809 Biel/Bienne | N/A | Switzerland | 7.24608 | 47.13713 Chur | N/A | Switzerland | 9.53287 | 46.84986 Kreuzlingen | N/A | Switzerland | 9.17504 | 47.65051 Lausanne | N/A | Switzerland | 6.63282 | 46.516 Lugano | N/A | Switzerland | 8.96004 | 46.01008 Sankt Gallen | N/A | Switzerland | 9.37477 | 47.42391 Zurich | N/A | Switzerland | 8.55 | 47.36667 Changhua | N/A | Taiwan | 120.5512 | 24.0692 Chiayi City | N/A | Taiwan | 120.44889 | 23.47917 Hualien City | N/A | Taiwan | 121.60444 | 23.97694 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Tainan City | N/A | Taiwan | 120.21333 | 22.99083 Tainan City | N/A | Taiwan | 120.21333 | 22.99083 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Khon Kaen | N/A | Thailand | 102.833 | 16.44671 Nonthaburi | N/A | Thailand | 100.51477 | 13.86075 Adana | N/A | Turkey (Türkiye) | 35.32531 | 36.98615 Adana | N/A | Turkey (Türkiye) | 35.32531 | 36.98615 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Izmir | N/A | Turkey (Türkiye) | 27.13838 | 38.41273 Kayseri | N/A | Turkey (Türkiye) | 35.48528 | 38.73222 Dnyepropetrovsk | N/A | Ukraine | N/A | N/A Dnyepropetrovsk | N/A | Ukraine | N/A | N/A Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Abu Dhabi | N/A | United Arab Emirates | 54.39696 | 24.45118 Dubai | N/A | United Arab Emirates | 55.30927 | 25.07725 Dubai | N/A | United Arab Emirates | 55.30927 | 25.07725 Sharjah city | N/A | United Arab Emirates | 55.41206 | 25.33737 Aberdeen | N/A | United Kingdom | -2.09814 | 57.14369 Bathampton | N/A | United Kingdom | -2.32279 | 51.39524 Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 Brighton | N/A | United Kingdom | -0.13947 | 50.82838 Cardiff | N/A | United Kingdom | -3.18 | 51.48 Chichester | N/A | United Kingdom | -0.78003 | 50.83673 Derby | N/A | United Kingdom | -1.47663 | 52.92277 Gateshead | N/A | United Kingdom | -1.60168 | 54.96209 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Kirkcaldy, Fife | N/A | United Kingdom | -3.15999 | 56.11683 Leeds | N/A | United Kingdom | -1.54785 | 53.79648 Leicester | N/A | United Kingdom | -1.13169 | 52.6386 Lincoln | N/A | United Kingdom | -0.53792 | 53.22683 Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Portadown, County Atrim | N/A | United Kingdom | -6.44434 | 54.42302 Rugby | N/A | United Kingdom | -1.26417 | 52.37092 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297 Stirling | N/A | United Kingdom | -3.93682 | 56.11903

1

NCT00153101

[ 5 ]

139

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

null

The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.

null

Renal Transplantation

Renal transplantation everolimus immunosuppressants wound-healing

null

2

arm 1: Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL. arm 2: Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.

[ 1, 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Everolimus (RAD001)

1

Basel | N/A | Switzerland | 7.57327 | 47.55839

1

NCT00154297

[ 4 ]

244

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption. BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive) fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the disc are water soluble, so the entire dosage form dissolves within 30 minutes of application.

null

Pain Cancer

Breakthrough Pain in Cancer Patients

null

1

arm 1: BEMA Fentanyl

[ 0 ]

1

[ 0 ]

intervention 1: buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily

intervention 1: BEMA Fentanyl

1

Austin | Texas | United States | -97.74306 | 30.26715

1

NCT00293020

[ 4 ]

804

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

null

Chronic Obstructive Pulmonary Disease (COPD)

COPD Lung function Exacerbations Quality of Life

null

2

arm 1: Aclidinium bromide 200 μg once-daily by inhalation arm 2: Placebo by inhalation

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks intervention 2: Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

intervention 1: Aclidinium bromide intervention 2: Placebo

120

1

NCT00358436

[ 3 ]

10

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.

null

Peanut Hypersensitivity

TOPS Peanut allergy Peanut-induced allergy Allergy

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: SC repeating dose

intervention 1: omalizumab

0

null

1

NCT00382148

[ 4 ]

307

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.

Schizophrenia and schizoaffective disorder are closely related in terms of symptoms, coexisting conditions, and genetic risk. In previous studies in patients with schizophrenia, treatment with paliperidone extended-release (ER) improved psychotic symptoms, as well as mood symptoms evaluated by anxiety/depression and hostility/excitement Positive and Negative Symptoms of Schizophrenia (PANSS) factor scores. Therefore, paliperidone ER may also be effective in treating symptoms of schizoaffective disorder. Paliperidone's limited potential for drug-drug interaction is particularly important in this patient population, in which multiple drug therapy is relatively common. This multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo-controlled, parallel-group study is designed to examine the effectiveness and safety of paliperidone ER in adult patients with schizoaffective disorder who are experiencing an acute episode of this disorder. Patients in the study will be randomly assigned to 1 of 2 groups to receive 6 weeks of oral treatment with flexible dosages of paliperidone ER (3-12 mg/day) or with placebo. The primary efficacy outcome will be the change from baseline to Week 6, or the last post-randomization assessment during double-blind treatment (endpoint), in the PANSS total score. Safety will be assessed by monitoring adverse events, clinical laboratory testing, pregnancy testing, vital signs measurements, physical examination, administration of a 12-lead ECG, movement disorders side effect scales, and the InterSePT Scale for Suicidal Thinking. Patients may also choose to participate in a pharmacogenomic (DNA) analysis. The primary study hypothesis is that flexible-dose paliperidone ER is better than placebo on the change from baseline in the PANSS total score in acutely ill patients with schizoaffective disorder. Patients will receive study drug by mouth for a total of 43 days. Beginning on Day 1, patients will take either placebo or paliperidone ER 6 mg/day. After day 4, dosages may be adjusted, at defined intervals, to a dosage between 3 mg/day and 12 mg/day, inclusive.

Schizoaffective Disorder Psychotic Disorder

Schizoaffective Disorder antipsychotic paliperidone placebo

null

3

arm 1: Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks) arm 2: Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks) arm 3: Placebo for 6 weeks

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: for 6 weeks intervention 2: (3-12mg/day in 3 mg/day increments for 6 weeks) intervention 3: (3-12mg/day in 3 mg/day increments for 6 weeks)

intervention 1: Placebo intervention 2: Paliperidone ER intervention 3: Paliperidone ER

44

Cerritos | California | United States | -118.06479 | 33.85835 Costa Mesa | California | United States | -117.91867 | 33.64113 Garden Grove | California | United States | -117.94145 | 33.77391 Huntington Beach | California | United States | -117.99923 | 33.6603 Pico Rivera | California | United States | -118.09673 | 33.98307 San Diego | California | United States | -117.16472 | 32.71571 Aventura | Florida | United States | -80.13921 | 25.95648 Hollywood | Florida | United States | -80.14949 | 26.0112 Kissimmee | Florida | United States | -81.41667 | 28.30468 Leesburg | Florida | United States | -81.87786 | 28.81082 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Charleston | South Carolina | United States | -79.93275 | 32.77632 Austin | Texas | United States | -97.74306 | 30.26715 Irving | Texas | United States | -96.94889 | 32.81402 Ahmedabad | N/A | India | 72.58727 | 23.02579 Ahmedibad | N/A | India | N/A | N/A Aurangabad | N/A | India | 75.34226 | 19.87757 Chennai | N/A | India | 80.27847 | 13.08784 Delhi | N/A | India | 77.23149 | 28.65195 Kanpur Uttarpradeh | N/A | India | N/A | N/A Pune | N/A | India | 73.85535 | 18.51957 Vadadora | N/A | India | N/A | N/A Ipoh | N/A | Malaysia | 101.0829 | 4.5841 Kota Kinabalu | N/A | Malaysia | 116.0724 | 5.9749 Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Kuching | N/A | Malaysia | 110.33333 | 1.55 Davao City | N/A | Philippines | 125.61278 | 7.07306 Mandaluyong | N/A | Philippines | 121.0409 | 14.5832 Manila | N/A | Philippines | 120.9822 | 14.6042 Pasig National Capitol Region | N/A | Philippines | N/A | N/A Arad | N/A | Romania | 21.31667 | 46.18333 Bucharest | N/A | Romania | 26.10626 | 44.43225 Câmpina | N/A | Romania | 25.73496 | 45.12619 Com Gura Ocnitei | N/A | Romania | N/A | N/A Iași | N/A | Romania | 27.6 | 47.16667 Piteşti | N/A | Romania | 24.86667 | 44.85 Daegu | N/A | South Korea | 128.59111 | 35.87028 Gyeonggi-do | N/A | South Korea | 126.76917 | 37.58944 Inchun | N/A | South Korea | N/A | N/A Jeonju | N/A | South Korea | 127.14889 | 35.82194 Kwangiu | N/A | South Korea | N/A | N/A Pusan | N/A | South Korea | 128.3681 | 36.3809 Seoul | N/A | South Korea | 126.9784 | 37.566

1

NCT00412373

[ 3 ]

1,146

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

true

This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.

null

Atrial Fibrillation Thromboembolism

Anti-coagulant Non-valvular Venous Thromboembolism Prevention of Blood Clots Atrial Fibrillation Non-valvular atrial fibrillation

null

5

arm 1: DU-176b 30mg tablet once daily arm 2: DU-176b 60mg once daily arm 3: DU-176b 30mg b.i.d. arm 4: DU-176b 60mg tablets two times a day arm 5: warfarin tablets

[ 0, 0, 0, 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 30mg tablet once daily intervention 2: 60mg tablet once daily intervention 3: 30mg tablet two times a day intervention 4: 60mg tablet two times a day intervention 5: warfarin tablets

intervention 1: Edoxaban (DU-176b) intervention 2: Edoxaban (DU-176b) intervention 3: Edoxaban (DU-176b) intervention 4: Edoxaban (DU-176b) intervention 5: warfarin

91

Huntsville | Alabama | United States | -86.58594 | 34.7304 Anaheim | California | United States | -117.9145 | 33.83529 Beverly Hills | California | United States | -118.40036 | 34.07362 Stockton | California | United States | -121.29078 | 37.9577 Orlando | Florida | United States | -81.37924 | 28.53834 Sarasota | Florida | United States | -82.53065 | 27.33643 Atlanta | Georgia | United States | -84.38798 | 33.749 Canton | Georgia | United States | -84.49076 | 34.23676 Fort Wayne | Indiana | United States | -85.12886 | 41.1306 Iowa City | Iowa | United States | -91.53017 | 41.66113 Cadillac | Michigan | United States | -85.40116 | 44.25195 Kalispell | Montana | United States | -114.31291 | 48.19579 Fremont | Nebraska | United States | -96.49808 | 41.43333 Santa Fe | New Mexico | United States | -105.9378 | 35.68698 Albany | New York | United States | -73.75623 | 42.65258 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Allentown | Pennsylvania | United States | -75.49018 | 40.60843 Pottstown | Pennsylvania | United States | -75.64963 | 40.24537 Sellersville | Pennsylvania | United States | -75.3049 | 40.35399 Dallas | Texas | United States | -96.80667 | 32.78306 Salt Lake City | Utah | United States | -111.89105 | 40.76078 Bellevue | Washington | United States | -122.20068 | 47.61038 Minsk | N/A | Belarus | 27.56653 | 53.90019 Brussels | N/A | Belgium | 4.34878 | 50.85045 Genk | N/A | Belgium | 5.50082 | 50.965 Banja Luka | N/A | Bosnia and Herzegovina | 17.19386 | 44.77842 Mostar | N/A | Bosnia and Herzegovina | 17.80806 | 43.34333 Sarajevo | N/A | Bosnia and Herzegovina | 18.35644 | 43.84864 Tuzla | N/A | Bosnia and Herzegovina | 18.66709 | 44.53842 Calgary | Alberta | Canada | -114.08529 | 51.05011 Edmonton | Alberta | Canada | -113.46871 | 53.55014 Alberta | British Columbia | Canada | N/A | N/A Winnipeg | Manitoba | Canada | -97.14704 | 49.8844 Oshawa | Ontario | Canada | -78.84957 | 43.90012 Thunder Bay | Ontario | Canada | -89.25018 | 48.38202 Montreal | Quebec | Canada | -73.58781 | 45.50884 Sherbrooke | Quebec | Canada | -71.89908 | 45.40008 Antofagasta | N/A | Chile | -70.39752 | -23.65094 Osorno | N/A | Chile | -73.13348 | -40.57395 Santiago | N/A | Chile | -70.64827 | -33.45694 Temuco | N/A | Chile | -72.59738 | -38.73628 Daugavpils | N/A | Latvia | 26.53333 | 55.88333 Riga | N/A | Latvia | 24.10589 | 56.946 Ventspils | N/A | Latvia | 21.56121 | 57.39485 Córdoba | N/A | Mexico | -96.92559 | 18.8842 Guadalajara Jalisco | N/A | Mexico | N/A | N/A Mexico City | N/A | Mexico | -99.12766 | 19.42847 Chisinau | N/A | Moldova | 28.85938 | 47.00902 Arkhangelsk | N/A | Russia | 40.55291 | 64.54717 Barnaul | N/A | Russia | 83.7456 | 53.3598 Chelyabinsk | N/A | Russia | 61.42915 | 55.15402 Ivanovo | N/A | Russia | 40.97139 | 56.99719 Kaliningrad | N/A | Russia | 20.51095 | 54.70649 Kazan' | N/A | Russia | 49.12214 | 55.78874 Kemerovo | N/A | Russia | 86.08333 | 55.33333 Krasnodar | N/A | Russia | 38.97603 | 45.04484 Krasnoyarsk | N/A | Russia | 92.90765 | 56.02668 Moscow | N/A | Russia | 37.61556 | 55.75222 N.Novgorod | N/A | Russia | N/A | N/A Novosibirsk | N/A | Russia | 82.94339 | 55.03442 Orenburg | N/A | Russia | 55.0988 | 51.7727 Penza | N/A | Russia | 45.00464 | 53.20066 Perm | N/A | Russia | 56.25017 | 58.01046 Rostov-on-Don | N/A | Russia | 39.72328 | 47.23135 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Samara | N/A | Russia | 50.15 | 53.20007 Saratov | N/A | Russia | 46.00861 | 51.54056 Tomsk | N/A | Russia | 84.98204 | 56.50032 Tula | N/A | Russia | 37.61822 | 54.19609 Tyumen | N/A | Russia | 65.52722 | 57.15222 Volgograd | N/A | Russia | 44.50183 | 48.71939 Yaroslavl | N/A | Russia | 39.87368 | 57.62987 Bardejov | N/A | Slovakia | 21.27271 | 49.29175 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Košice | N/A | Slovakia | 21.25808 | 48.71395 Lučenec | N/A | Slovakia | 19.66708 | 48.33249 Prešov | N/A | Slovakia | 21.23393 | 48.99839 Cherkassy | N/A | Ukraine | 32.05738 | 49.44452 Chernihiv | N/A | Ukraine | 31.28656 | 51.50541 Chernivtsy | N/A | Ukraine | N/A | N/A Dnipro | N/A | Ukraine | 35.04066 | 48.46664 Donetsk | N/A | Ukraine | 37.80224 | 48.023 Ivano-Frankivsk | N/A | Ukraine | 24.71248 | 48.92312 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Lutsk | N/A | Ukraine | 25.35024 | 50.75784 Lviv | N/A | Ukraine | 24.02324 | 49.83826 Odesa | N/A | Ukraine | 30.74383 | 46.48572 Poltava | N/A | Ukraine | 34.55367 | 49.58925 Ternopil | N/A | Ukraine | 25.59067 | 49.55404 Vinnitsa | N/A | Ukraine | 37.71861 | 49.84639 Zaporizhzhya | N/A | Ukraine | 35.11714 | 47.85167

1

NCT00504556

[ 3 ]

5

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This protocol will test a humanized monoclonal antibody known as Campath-1H for its ability to induce a state of permanent allograft acceptance, or tolerance, when administered in combination with a brief course of the immunosuppressive drug deoxyspergualin (DSG) at the time of human renal allotransplantation. Campath-1H is specific for the common lymphocyte and monocyte antigen CD52. Its administration temporarily depletes mature lymphocytes and some monocytes without altering neutrophils or hematopoietic stem cells. Deoxyspergualin inhibits the NFkB pathway thus preventing monocyte and macrophage activation. Recipients of living or cadaveric donor kidneys will be treated with one dose of Campath-1H prior to transplantation to insure that peripheral depletion is achieved at the time of graft reperfusion. Three subsequent doses of Campath-1H will be administered on the first, third and fifth days after the transplant to deplete passenger donor leukocytes and residual recipient cells that mobilize in response to the allograft. In addition, patients will be treated with DSG for 14 days beginning on the day prior to surgery. This trial expands on pilot studies at the NIH of 15 patients in which Campath was given alone at the time of transplantation. In those studies, excellent peripheral depletion occurred after just one dose of Campath though central depletion required additional dosing. This allowed for greatly reduced immunosuppression to be used to prevent rejection, but to date, all patients have required some immunosuppressive medication. It is hoped that the addition of DSG will eliminate the need for long-term immunosuppression. Patients will be followed closely in the post transplant period. If patients experience rejection, they will be treated with methylprednisolone and have immunosuppression added using sirolimus as the predominant immunosuppressive agent. In the previous phase of this study without DSG, this maneuver has in all cases been successful in returning the allograft to normal function. In addition to evaluating graft function following transplantation, this protocol will also characterize and evaluate the function of the immune system and the composition of the T cell repertoire following the administration of Campath-1H and DSG, and during immune system recovery after transplantation.

This protocol will test a humanized monoclonal antibody known as Campath-1H for its ability to induce a state of permanent allograft acceptance, or tolerance, when administered in combination with a brief course of the immunosuppressive drug deoxyspergualin (DSG) at the time of human renal allotransplantation. Campath-1H is specific for the common lymphocyte and monocyte antigen CD52. Its administration temporarily depletes mature lymphocytes and some monocytes without altering neutrophils or hematopoietic stem cells. Deoxyspergualin inhibits the Rel-B/ NFkB pathway thus preventing monocyte and macrophage activation. Extensive preliminary data have been accumulated in humans using Campath-1H and its non-humanized predecessors. Additionally, data have been generated using a similar depleting scheme with and without DSG in non-human primates. Both the human and non-human primate data suggest that profound mature mononuclear cell depletion establishes a window of opportunity during which foreign tissue can be transplanted without the need for additional immunosuppression. Regulatory events occuring during mature cell repopulation in the presence of allografted tissue created a state in which the graft may not be rejected even in the absence of chronic immunosuppression. Recipients of living or cadaveric donor kidneys will be treated with one dose of Campath-1H prior to transplantation to insure that peripheral depletion is achieved at the time of graft reperfusion. Three subsequent doses of Campath-1H will be administered on the first, third and fifth days after the transplant to deplete passenger donor leukocytes and residual recipient cells that mobilize in response to the allograft. In addition, patients will be treated with DSG 4mg/kg/d x 1 beginning on day 12 and then 2.5 mg/kg/d for an additional 13 days. This trial expands on pilot studies at the NIH of 17 patients in which Campath was dosed both prior to and after transplantation with and without DSG. In those studies, excellent peripheral depletion occured after just one dose of Campath though central depletion required additional dosing. Thus, the goal of pre-reperfusion depletion can be achieved with a single pre-operative dose but thorough depletion requires additional post-operative dosing. Lasting rejection-free survival was not realized without the addition of some, albeit reduced immunosuppression. This is thought to be due to residual post-operative monocytes that infiltrated the allograft causing modest reversible allograft dysfunction. The current dosing regimen with DSG is thus designed to accomplish both pre-operative depletion, and more thorough post operative elimination of donor and recipient cells mobilizing as a result of reperfusion, combined with therapy aimed at preventing the activation of monocytes that escape depletion. The timing of the DSG is meant to correspond with the peripheral repopulation of monocytes seen in previous patients. Patients will be followed closely in the post transplant period for evidence of a detrimental immune response to the allograft. In the previous patients experiencing graft directed immunity the graft dysfunction was preceded by a rise in activated monocytes in the peripheral blood and augmented transcription of the cytokine Tumor Necrosis Factor-alpha (TNF-a) in the allograft. This syndrome has been resistant to treatment with the TNF-a sequestrant Infliximab and is now thought to require more comprehensive monocyte directed therapy. If patients progress and graft dysfunction occurs, patients will be treated with methylprednisolone and have immunosuppression added using sirolimus as the predominant immunosuppressive agent. This maneuver has in all cases been successful in returning the allograft to normal function. Sirolimus has been chosen since it does not act by interfering with specific T cell receptor function, and thus, provides immunosuppressive coverage during cell repopulation without interfering with the antigen specific T cell events important for tolerance induction. Non-human primate and human clinical data support both of these approaches. In addition to evaluating graft and patient outcome following transplantation, this protocol will also characterize and evaluate the function of the immune system and the composition of the T cell repertoire following the administration of Campath-1H and DSG, and during immune system recovery after transplantation.

Graft Rejection Kidney Disease

Immunosuppression Tolerance DSG Alemtuzumab

null

1

arm 1: The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.

[ 0 ]

1

[ 0 ]

intervention 1: Alemtuzumab was administered intravenously at 0.3 mg/kg/dose over 3 hr. Patients received one dose on each of days -1,+1,+3 and +5 relative to transplantation (total dose 1.2 mg/kg). Methylprednisolone was given prior to each dose to limit the cytokine release: 500 mg prior to dose 1, 125 mg prior to dose 2, and 60 mg prior to doses 3 and 4. Deoxyspergualin was dosed as follows. The first two patients received 4 mg/kg as a loading dose on the day of transplant and 2.5 mg/kg daily for 13 additional days (14 days of treatment; 36.5 mg/kg total dose). The next three patients received the same dosing regimen but it was initiated on postoperative day 12 to coincide with the resurgence of monocytes on days 12- 25.

intervention 1: Alemtuzumab and DSG

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00001984

[ 3 ]

50

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This is a large scale study involving fluoxetine (Prozac) versus a placebo in the treatment of adolescents with alcohol use disorder (AUD) and major depression (MDD). All individuals will receive treatment for 12 weeks with a followup phase lasting 9 months.

Recently, the first large-scale double-blind, placebo-controlled study of a selective serotonin reuptake inhibitor (SSRI) antidepressant in depressed adolescents was completed (Emslie et al., 1997) That study demonstrated efficacy for fluoxetine in non-AUD adolescents with major depressive disorder (MDD). Our own research group recently completed a first double-blind, placebo-controlled study of fluoxetine in adults with comorbid MDD and alcohol dependence (Cornelius et al., 1997). That study demonstrated efficacy for fluoxetine in decreasing both the depressive symptoms and the alcohol use of adult depressed alcoholics. Our own research group also recently completed a pilot study involving open label fluoxetine in adolescents with comorbid AUD and MDD. That pilot study demonstrated within-group efficacy for fluoxetine for decreasing both the drinking and the depressive symptoms of that population, and suggested that fluoxetine is a safe medication in this population (Cornelius, et al., In Press). However, to date, no double-blind, placebo-controlled study of any selective serotonin re-uptake inhibitors (SSRI) medication has been conducted in adolescents with a comorbid AUD and MDD. In this proposed study, a first large scale prospective double-blind, placebo-controlled study will be undertaken involving the SSRI medication fluoxetine versus placebo in the treatment of adolescents with an alcohol use disorder and major depression (AUD/MDD). The goals of the study include the following: 1) to compare the efficacy of the SSRI medication fluoxetine plus Treatment As Usual (TAU) to placebo plus TAU for the alcohol use and the depressive symptoms of an adolescent sample (ages 15 to 18) of subjects with comorbid diagnoses of an AUD and MDD; 2) to assess specific predictors of medication response in that study; and to perform a preliminary evaluation of the longer-term efficacy of fluoxetine in these patients, in a 9-month naturalistic follow-up period beyond the 3 month acute phase study. We hypothesize that fluoxetine plus TAU will demonstrate efficacy for decreasing both the drinking and the depressive symptoms of this population.

Alcoholism Depression

fluoxetine, adolescents, alcohol dependence, major depression Alcoholism

null

2

arm 1: fluoxetine plus Treatment As Usual (TAU) arm 2: placebo plus Treatment As Usual (TAU)

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up intervention 2: placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up

intervention 1: fluoxetine (Prozac) intervention 2: Placebo plus Treatment As Usual

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00027378

[ 3, 4 ]

150

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplantation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.

null

Primary Sclerosing Cholangitis

Urso PSC

null

2

arm 1: Placebo tablet that is identical (size, color, etc) to experimental ursodeoxycholic acid tablet. arm 2: Ursodeoxycholic acid 28-30 mg/kg/day

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses intervention 2: Placebo for Urso

intervention 1: Ursodeoxycholic Acid intervention 2: Placebo

7

0

NCT00059202

[ 3 ]

241

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

1FEMALE

false

Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus available for bone building. Teriparatide is a drug that reduces the risk of fractures by increasing bone thickness and strength. Vitamin D is also necessary for strong bones and teeth. The purpose of this study is to evaluate the bone-building effectiveness of two calcium supplements, one with a source of phosphorus and one without, in combination with teriparatide and vitamin D in women with osteoporosis.

Osteoporosis is the most common type of bone disease. Calcium supplements normally used in anti-osteoporosis treatment are calcium salts of carbonate or citrate; however, these salts bind phosphorus from food in the intestine and restrict phosphorus available for bone building. This study will evaluate the efficacy of adding calcium phosphate to a regimen of teriparatide and vitamin D in increasing bone mineral density in women with osteoporosis. It is hypothesized that the group taking the phosphate-containing calcium supplement will have greater gains in bone mineral density (BMD) during the course of the study than the group not receiving phosphate. All participants will receive teriparatide and vitamin D during the course of the 12-month study. Participants will be randomly assigned to one of two groups. One group will receive calcium phosphate and the other will receive calcium carbonate. BMD will be measured at spine and hip at baseline and at 3, 6, and 12 months of treatment.

Osteoporosis Osteopenia

Bone Mineral Density Calcium

null

2

arm 1: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate. arm 2: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate. intervention 2: Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.

intervention 1: Calcium carbonate intervention 2: Calcium Phosphate

1

Omaha | Nebraska | United States | -95.94043 | 41.25626

0

NCT00074711

[ 3 ]

106

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This is a study of E7389 in patients with recurrent and/or metastatic Non-Small-Cell Lung Cancer (NSCLC) who progressed during or after treatment with a platinum agent and another chemotherapy.

null

Non-Small-Cell Lung Carcinoma

null

2

arm 1: E7389 28 day cycle arm 2: E7389 21 day cycle

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: E7389 1.4 mg/m\^2 IV bolus on Days 1, 8, and 15 of a 28 day cycle. intervention 2: E7389 1.4 mg/m\^2 IV bolus on Days 1 and 8 of a 21 day cycle.

intervention 1: E7389 28 Day Cycle intervention 2: E7389 21 Day Cycle

13

0

NCT00100932

[ 3 ]

16

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with capecitabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with capecitabine works as first-line therapy in treating older patients with metastatic colorectal cancer.

OBJECTIVES: Primary * Determine the time to disease progression in older patients with metastatic colorectal cancer treated with bevacizumab and capecitabine as first-line therapy. Secondary * Determine the response rate in patients treated with this regimen. * Determine the median survival of patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13-16 months.

Colorectal Cancer

recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer

null

1

arm 1: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7

[ 0 ]

2

[ 2, 0 ]

intervention 1: None intervention 2: None

intervention 1: bevacizumab intervention 2: capecitabine

1

Buffalo | New York | United States | -78.87837 | 42.88645

0

NCT00107315

[ 5 ]

27

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.

Post-traumatic stress disorder (PTSD) is characterized by three symptom groupings: re-experiencing symptoms including flashbacks, nightmares, and intrusive memories; physiological hyperarousal; and avoidance symptoms. Of the three major categories of symptoms in PTSD listed by the Diagnostic and Statistical Manual of Mental Disorders, sleep-related problems are listed in two of them: difficulty falling asleep is considered an aspect of hyperarousal symptoms, and nightmares are a type of re-experiencing symptom. Both are found commonly in PTSD. Little is known about the relationship of neuroendocrine dysregulation in PTSD and sleep disturbance. It is possible that successful treatment of sleep disturbance in PTSD may alter an abnormal stress hormone pattern. The novel cyclopyrrolone hypnotic eszopiclone thus presents an intriguing opportunity to examine the treatment of sleep disturbances and nightmares in PTSD. This study will determine the safety, efficacy and impact on neuroendocrine parameters of eszopiclone compared to placebo for sleep disturbance and overall PTSD symptoms in individuals with PTSD and reported sleep disturbance.

Post-Traumatic Stress Disorders

PTSD Sleep disturbance Eszopiclone Double-blind Crossover

null

2

arm 1: Subjects received 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout. arm 2: Subjects received placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.

[ 0, 2 ]

1

[ 0 ]

intervention 1: The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.

intervention 1: Eszopiclone

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00120250

[ 5 ]

219

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.

null

HIV-Associated Lipodystrophy Syndrome

HIV infections

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Capsules, Oral, ATV 300 mg + RTV 100 mg once daily up to 96 weeks intervention 2: Protease inhibitor \[PI\] combination + 2 NRTIs

intervention 1: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs) intervention 2: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)

30

Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 Honolulu | Hawaii | United States | -157.85833 | 21.30694 Huntersville | North Carolina | United States | -80.84285 | 35.41069 Houston | Texas | United States | -95.36327 | 29.76328 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Toronto | Ontario | Canada | -79.39864 | 43.70643 Bondy | N/A | France | 2.48931 | 48.9018 Lagny-sur-Marne | N/A | France | 2.71667 | 48.86667 Lyon | N/A | France | 4.84671 | 45.74846 Nice | N/A | France | 7.26608 | 43.70313 Paris | N/A | France | 2.3488 | 48.85341 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 München | N/A | Germany | 13.31243 | 51.60698 Brescia | N/A | Italy | 10.21472 | 45.53558 Milan | N/A | Italy | 12.59836 | 42.78235 Modena | N/A | Italy | 10.92539 | 44.64783 Roma | N/A | Italy | 11.10642 | 44.99364 Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738 Zapopan | Jalisco | Mexico | -103.38742 | 20.72111 Puebla City | N/A | Mexico | -98.20723 | 19.04778 Szczecin | N/A | Poland | 14.55302 | 53.42894 Wroclaw | N/A | Poland | 17.03333 | 51.1 Barcelona | N/A | Spain | 2.15899 | 41.38879 Elche (Alicante) | N/A | Spain | -0.70107 | 38.26218 Guipuzcoa | N/A | Spain | N/A | N/A Madrid | N/A | Spain | -3.70256 | 40.4165 Málaga | N/A | Spain | -4.42034 | 36.72016 Valencia | N/A | Spain | -0.37966 | 39.47391 Brighton | East Sussex | United Kingdom | -0.13947 | 50.82838 London | Greater London | United Kingdom | -0.12574 | 51.50853

0

NCT00135356

[ 4 ]

255

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

null

Epilepsy, Partial

Partial Onset Seizures levetiracetam Epilepsy Keppra

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.

intervention 1: levetiracetam (LEV)

84

0

NCT00152516

[ 3 ]

105

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

false

Time to progression (physical examination and radiologic imaging

null

Ovarian Cancer

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®

intervention 1: Paclitaxel

0

null

0

NCT00158379

[ 5 ]

15

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

false

Obesity is known to affect the concentrations of certain medications in the body. Levofloxacin is a commonly used antibiotic. Based on what the investigators know about levofloxacin and how it moves through the body, obesity may affect levofloxacin concentrations. This study aims to show the effect of obesity on levofloxacin concentrations. The hypothesis is as follows: A 750 mg intravenous (IV) dose of levofloxacin administered to severely obese, critically ill patients will yield serum concentrations that are likely to be therapeutic.

Although the pharmacokinetics of levofloxacin have been consistent in various study populations, obese and critically ill individuals are likely to demonstrate altered distribution and clearance of levofloxacin, in addition to potentially having altered serum concentrations. Thus, the following study proposes to address the question: What are the effects of the combination of critical illness and severe obesity on the pharmacokinetics of levofloxacin. The data from this investigation will also be combined with obese ambulatory volunteer data to more accurately define the effects of obesity on the pharmacokinetic parameters of levofloxacin. There are no comparisons in this study. The specific aims are: 1. Characterize pharmacokinetic parameters of levofloxacin in obese critically ill individuals: Cmax, Tmax, area under the concentration-time curve (AUC), volume of distribution, elimination rate, serum half-life, and urine clearance. 2. Determine the percentage of patients that achieve an AUC/MIC ratio\* of 88, which is achieved in 72% of non-obese, non-critically ill patients and is correlated with efficacy. Hospitalized subjects will be identified by medical or pharmacy house staff officers providing care in the intensive care unit and through computerized medication profiles provided by UKCMC or UTMB Pharmacy Services. Once an investigator determines eligibility, a recommendation will be made to enroll the patient in the study to the attending physician. After obtaining permission to enroll the subject, the investigator will obtain informed consent from the patient or his/her appropriate surrogate. The decision of competence will be made by the physician, in conjunction with family members, if available. Assessment of competence for providing informed consent will be documented in the medical record via the statement below: "The patient was fully assessed and is/is not competent to agree to the study. Family members, including the patient's surrogate, were present for the assessment and agree the patient is/is not competent for purposes of study entry. This assessment and conversation with the family was witnessed by nurse assigned to the patient's care." The informed consent document will be signed and an original copy will be placed in the patient's medical record. No study related orders will be written until the signed consent form is included in the medical record. Ambulatory subjects will be identified by medical staff. Participants are likely to be recruited from physician clinics such as sleep clinic. Research Procedures: Ambulatory volunteers will be admitted for 24 hours to the UTMB or UK General Clinical Research Center. Hospitalized participants will be admitted to the UKCMC or UTMB hospital for reasons other than participation in the study. Each participant will receive a 750 mg intravenous levofloxacin dose. A peripheral intravenous catheter will be placed in each arm for drug administration and serial blood sampling. Pre-existing intravenous access will be utilized when possible. Baseline serum chemistry and complete blood count will be obtained for each individual prior to the levofloxacin dose for screening purposes. Subjects will rest in a supine position while receiving a 750 mg intravenous dose of levofloxacin over 90 minutes. Serial blood samples will be obtained 1.5, 3, 4, 5, 8, 12, and 24 hours after the beginning of administration of levofloxacin. Urine collection will also be completed during the 24 hour study period. Venous blood samples will be collected in 10 ml standard red-top vacuum tubes. The samples will be centrifuged for 10-15 minutes at 5000 rpm, the serum removed, and placed in a plastic vial suitable for freezing. The samples will be placed in a -80oC freezer until ready for shipment to the site for assay. Urine will also be collected during the 24 hour study period to assess renal function as well as measure drug elimination. Two aliquots will be extracted from the total urine volume: one for levofloxacin assay (storage procedure as above) and one for urine creatinine measurement (for 24 hour creatinine clearance). Urine aliquots and serum samples will be transported to the University of Kentucky College of Pharmacy for levofloxacin assay. Ambulatory participants at the University of Texas Medical Branch will undergo a whole body potassium-40 counter scan in order to determine the percentage of adipose and lean body mass. This will consist of subjects lying in a supine position for 30 to 45 minutes under the whole body counter that is housed in the General Clinical Research Center at the University of Texas Medical Branch. The ambulatory volunteers will be scanned during the 24 hour study period. Initial data to be collected include: age, height, weight, admitting diagnosis, serum creatinine, blood urea nitrogen, fluid intake/output, concomitant medications, concomitant disease states that might affect pharmacokinetics, any operating room procedures, documented or suspected infection site, pertinent microbiological culture results, and adverse drug reactions. Levofloxacin pharmacokinetics will be analyzed assuming a two-compartment model with first order elimination using WinNonLin 4.01 (Pharsight Corp, Mountainview, CA). Patients will be followed for 24 hours.

Obesity Critical Illness

null

1

arm 1: Patients receiving levofloxacin 750mg IV

[ 0 ]

1

[ 0 ]

intervention 1: PK in obesity

intervention 1: Levofloxacin 750 mg IV

1

Lexington | Kentucky | United States | -84.47772 | 37.98869

0

NCT00176306

[ 3 ]

50

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

To determine the activity of lenalidomide in relapsed or refractory aggressive NHL.

null

Non-Hodgkins Lymphoma

celgene cc-5013 CC5013 NHL Non-Hodgkins Lymphoma Revlimid

null

1

arm 1: Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.

[ 0 ]

1

[ 0 ]

intervention 1: Capsules for oral administration.

intervention 1: Lenalidomide

8

0

NCT00179660

[ 3 ]

4

RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

null

The subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (DCIS). This condition is associated with the development of breast cancer in up to 50% of cases. The subjects are being asked to participate in this research study. They are being offered voluntary admission to this study to test the effects of a new investigational drug called Fulvestrant (Faslodex). This drug is approved by the United States Food and Drug Administration (FDA) for the treatment of advanced breast cancer but has not been approved for the treatment of DCIS. However, the FDA has given permission for the drug to be tested in this study. The purpose of this study is to find out if Fulvestrant has any effect on the subject's precancerous changes by comparing samples taken before and after receiving Fulvestrant.

null

Breast Carcinoma

null

4

arm 1: None arm 2: Tamoxifen 20 mg arm 3: Fulvestrant 250mg arm 4: Fulvestrant 500mg IM

[ 4, 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 20mg intervention 2: 250mg intervention 3: 500 mg IM

intervention 1: Tamoxifen intervention 2: Fulvestrant intervention 3: Fulvestrant

1

Los Angeles | California | United States | -118.24368 | 34.05223

0

NCT00183963

[ 0 ]

18

NA

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

false

0ALL

true

We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.

Subjects with mild allergic asthma are examined before, immediately after and 2 months after a course of treatment with anti-IgE. The following are examined: Allergen skin tests, allergen induced asthma, peripheral blood basophils, pulmonary bronchial mucosal mast cells.

Asthma

null

1

arm 1: This is a single arm, parallel study examining differences of therapeutic outcomes of Xolair. Xolair is being examined as an intervention that might change the outcome of immunization.

[ 0 ]

1

[ 0 ]

intervention 1: Patients are administered Xolair

intervention 1: Xolair

1

Albuquerque | New Mexico | United States | -106.65114 | 35.08449

0

NCT00189228

[ 5 ]

130

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.

null

Schizophrenia Schizoaffective Disorder

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 5-20 mg, oral, capsules, daily, 12 weeks. intervention 2: 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.

intervention 1: olanzapine intervention 2: risperidone

1

San Diego | California | United States | -117.16472 | 32.71571

0

NCT00190749

[ 4 ]

355

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.

null

Bladder Neoplasms

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT) intervention 2: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

intervention 1: Gemcitabine intervention 2: Placebo

1

Reinfeld | N/A | Germany | 10.49227 | 53.8311

0

NCT00191477

[ 5 ]

37

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

Polycystic ovary syndrome (PCOS) affects 5-10% of women in the United States. Its onset is usually at the time of puberty with manifestations of menstrual irregularity, hirsutism, and obesity. Women with PCOS suffer at an early stage of adulthood from all of the components of the metabolic syndrome, a syndrome that typically has its peak in mid-life in other subject populations. Women with PCOS are more insulin resistant than weight-matched control women and have exceptionally high rates of early-onset impaired glucose tolerance and type 2 diabetes, as well as a substantially elevated risk for hypertension, dyslipidemia, coronary, and other vascular diseases. While recent evidence indicates that the prevalence of sleep-disordered breathing (SDB) is 30-40 fold higher in PCOS than in weight-matched control women, the possible role of SDB in causing the increased metabolic and cardiovascular risks of PCOS has not been evaluated. The overall objective of the proposed study is to analyze the direction of causality between sleep disturbances and markers of the metabolic syndrome in PCOS.

Polycystic ovary syndrome (PCOS) affects 5-10% of women and may be viewed as the combination of hyperandrogenism with the classical features of the metabolic syndrome in young women. PCOS presents a unique opportunity to dissect the relationship between metabolic and cardiovascular risk and sleep disordered breathing (SDB) in a population where intrinsic effects of aging have not yet developed. Because a relationship between obstructive sleep apnea, insulin resistance and elevated testosterone levels has also been observed in men and in women without PCOS, insights gained from studies in PCOS will have broad implications. The Specific Aims of the present application are: Specific Aim 1: to test the hypothesis that sleep disturbances are caused by hyperandrogenemia and hyperinsulinemia that characterize PCOS. Following a detailed baseline evaluation of sleep, hormonal, metabolic and cardiovascular parameters, women with PCOS will be randomized to an 8-week treatment phase with pioglitazone or depot leuprolide plus estrogen/progestin replacement or placebo. Pioglitazone will reduce insulin levels, and consequently androgen levels, in PCOS. We will compare the effects of androgen reduction alone (depot leuprolide plus estrogen/progestin) to those of insulin plus androgen reduction achieved with pioglitazone. Primary comparisons will be the change in sleep parameters from baseline between: placebo \& pioglitazone; placebo \& leuprolide/estrogen/progestin; pioglitazone \& leuprolide/estrogen/progestin. Specific Aim 2: to test the hypothesis that sleep disturbances cause the hormonal, metabolic and cardiovascular alterations seen in women with PCOS. PCOS women with SDB and matched control women with SDB will be evaluated at baseline and following 8 weeks of CPAP treatment. The primary comparison will be between baseline and post-treatment parameters in PCOS women. The secondary comparison will be the post-treatment change from baseline between PCOS and control women to test the hypothesis that for the same degree in improvement in SDB, the magnitude of change in metabolic and cardiovascular measures will be greater in PCOS than in controls. Specific Aim 3: to test the hypothesis that in normal young women, experimental manipulation of sleep that recapitulates the sleep disturbances characteristic of women with PCOS will result in metabolic, hormonal, and cardiovascular alterations that are typical of the metabolic syndrome. A group of healthy young women will be studied twice using a randomized cross-over design. In one study, rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed. In the other, slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed. Each study will be preceded by 2 nights of baseline sleep. Results were not reported for Aim 3 since no devices or drugs were tested in this aim.

Polycystic Ovary Syndrome Obstructive Sleep Apnea

polycystic ovary syndrome metabolic syndrome obstructive sleep apnea impaired glucose tolerance insulin resistance

null

10

arm 1: One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm. arm 2: One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm. arm 3: One of the 3 treatment arms in Aim 1: depot leuprolide plus estrogen/progestin replacement. No subjects were randomized to this arm. arm 4: One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP). arm 5: One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP). The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size. arm 6: Each subject was assessed under three experimental conditions in the following order. REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed. Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed. Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention. arm 7: Each subject was assessed under three experimental conditions in the following order. REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed. Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention. SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed. arm 8: Each subject was assessed under three experimental conditions in the following order. Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention. REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed. SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed. arm 9: Each subject was assessed under three experimental conditions in the following order. SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed. REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed. Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention. arm 10: Each subject was assessed under three experimental conditions in the following order. Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention. SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed. REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.

[ 4, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]

5

[ 1, 0, 0, 3, 3 ]

intervention 1: CPAP is the most effective treatment available for sleep disordered breathing. CPAP provides a constant, controllable pressure to keep your upper airway open during sleep so that you can breathe normally. The pressure acts much in the same way as a splint and holds the airway open. intervention 2: Depot leuprolide is a long-acting, modified version of the natural brain hormone, gonadotropin releasing hormone (GnRH). This study drug will temporarily reduce the pituitary hormones that stimulate the ovaries to make both female (estrogen) and male (testosterone) hormones. The effect of this study drug will last approximately 12 weeks. During this time, your female hormone levels will be brought to normal by the use of a patch that contains estrogen and progesterone. This patch is placed on the skin and is changed twice a week. The subject will continue to wear this patch for 4 weeks after the end of the study, until the effects of the Lupron injection wear off. intervention 3: Pioglitazone (Actos). Pioglitazone is an oral medication approved in the Unites States for the treatment of patients with type 2 diabetes (however it is not approved for studies in this protocol). This is one of a class of drugs known as thiazolidinediones. This class of drugs has been associated with potential beneficial changes in the metabolism (use of glucose by the body) as well as lipids (fats) in the blood. intervention 4: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed. intervention 5: SWS: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.

intervention 1: continuous positive airway pressure (CPAP) intervention 2: depot leuprolide plus estrogen/progestin replacement intervention 3: pioglitazone intervention 4: REM frag intervention 5: SWS supp

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00203996

[ 0 ]

12

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Ultrasound is a technique that can provide images of the blood vessels such as arteries. The size of the arteries, such as the main blood vessel in the arm, can change under different conditions. Using ultrasound we can see how arteries change with movement or even drugs. We want to use ultrasound to see how blood vessels look in patients with Congestive Heart Failure (CHF) and to also see how a drug called Spironolactone, commonly prescribed for patients with this disease, effects blood vessel function in patients with congestive heart failure. This information may be used to change the standard of care for patients with heart failure especially if we show that Spironolactone has a positive effect on vessel function in patients with CHF.

Spironolactone The starting dose of spironolactone is 1 mg/kg/day. After two weeks this dose will be doubled to the same maximum dose (2/mg/kg/day) as in RALES. If side effects occur or plasma urea and electrolytes became deranged the dose will be halved. Patients unable to tolerate the minimum dose will be withdrawn. Measurement of serum electrolytes will occur at baseline, at two weeks, and at time of repeat evaluation. Endothelial Function Subjects with single ventricle will have an evaluation of endothelial function: 1. At baseline 2. On spironolactone- 4-5 weeks after initial study. Imaging protocol: The diameter of the brachial artery will be measured from two-dimensional ultrasound images, using a 12 MHz linear array transducer and an Accuson Sequoia system (Accuson, Mountainview, California). Measurements of the brachial artery will be obtained: 1. In a resting state 2. During limb ischemia 3. In response to reactive hyperemia 4. At rest Reactive hyperemia will be induced by inflating a standard blood pressure cuff to 50 mm Hg above the systolic blood pressure for 4.5 minutes and then deflating the cuff. After data collection, the DICOM-formatted images will be transferred to a PC for investigator-blinded measurement of brachial artery diameter using image analysis software (Brachial Tools 3.1, Medical Imaging Applications, Iowa). Measurement of prognostic markers: Blood samples Plasma beta-type natriuretic peptide, form assay, TNF alpha and a Cytokine panel will be drawn at base line and at the final 4-5 week visit for this study. Samples will be collected between 11 am and 1 pm after 30 minutes' supine rest. The samples will be centrifuged and plasma stored at -70°C (peptides) or -20°C (other samples). Plasma \[beta\]-type natriuretic peptide (BNP) samples will be collected into EDTA and aprotonin and measured by radioimmunoassay 6-minute walk test. A 6-minute walk test will be performed at the first visit and the last visit. During this test, signs and symptoms will be recorded (i.e. chest pain and shortness of breath) to determine toleration of daily activity. A doctor or nurse will conduct this test and the patient will be provided the opportunity to stop or rest if symptoms become severe. Outcome measures The primary outcome measure will be the change in flow mediated dilation (during reactive hyperemia). This will be expressed as a percentage. Secondary outcome measures will include changes in BNP, Form assay, TNF alpha, Cytokine panels and the 6-minute walk test. Statistical analysis We and others have previously shown that asymptomatic patients with the Fontan operation have a mean flow-mediated dilation of approximately 4% compared to 8-9% in controls. In order to detect a 25% change in FMD, with a power of 0.80, the current study would require a patient population of 13 cases. There are currently over 40 patients with single ventricle who are followed in the adult congenital clinic at Emory University. We plan on enrolling 20 patients into this study.

Congenital Disorders

Congenital Heart Disease Spironolactone >17 years old undergone Fontan procedure endothelial function

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 1 mg/kg/day; afer 2 weeks doubled to 2/mg/kg/day. Patient's with endothelium-dependent brachial artery vasodilation and single-ventricle should show improvement within 4-8 weeks. Patients and their labs who are receiving Spironolactone will be followed.

intervention 1: Spironolactone (drug)

1

Atlanta | Georgia | United States | -84.38798 | 33.749

0

NCT00211081

[ 4 ]

50

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to evaluate the change in brachial artery reactivity in HIV-infected subjects with elevated lipid levels who are switched to an atazanavir containing antiretroviral regimen

HIV-infected subjects on a stable protease inhibitor (PI) containing antiretroviral regimen with plasma HIV RNA \<500 copies/mL, who have LDL cholesterol levels \>130 mg/dL or fasting triglycerides levels \>200 mg/dL, will be randomized (1:1) to continue their current antiretroviral regimen or to switch the PI to atazanavir (ATV). Brachial artery reactivity will be measured before (at entry) and 12 and 24 weeks after subjects are randomized. ARM A: Switch current PI to atazanavir 400 mg once daily plus current \> 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks. Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (\<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily. ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus \> 2 NRTIs) for 24 weeks Brachial artery reactivity in response to two vasoactive stimuli (increased forearm blood flow and nitroglycerin) will be assessed by measuring brachial artery diameter.

HIV Infection Hyperlipidemia

Atazanavir Endothelial function Treatment Experienced

null

2

arm 1: ARM A: Switch current PI to atazanavir 400 mg once daily plus current \> 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks. Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (\<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily. arm 2: ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus \> 2 NRTIs) for 24 weeks

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: atazanavir 400 mg once daily intervention 2: Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus \> 2 NRTIs

intervention 1: Atazanavir intervention 2: current antiretroviral regimen

7

0

NCT00225017

[ 5 ]

18

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic disorder, a form of low-grade chronic depression. We hypothesize that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.

This is a ten-week, double-blind, placebo-controlled study designed to evaluate the tolerability, dosing and efficacy of Wellbutrin XL in outpatients who meet Diagnostic and Statistical Manual-IV criteria for early onset, primary type dysthymic disorder (low-grade chronic depression). It is hypothesized that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.

Dysthymic Disorder

Dysthymic Disorder Dysthymia Depression Chronic Depression Wellbutrin XL

null

2

arm 1: Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day arm 2: Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: Antidepressant medication intervention 2: Placebo

intervention 1: bupropion XL intervention 2: Placebo

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00225251

[ 3 ]

48

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

true

Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.

Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations

Breast Cancer

null

1

arm 1: single arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion

[ 0 ]

1

[ 0 ]

intervention 1: trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44

intervention 1: trastuzumab, docetaxel and carboplatin in dose dense regimen

1

Miami | Florida | United States | -80.19366 | 25.77427

0

NCT00232479

[ 4 ]

629

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.

This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.

Heartburn

null

2

arm 1: Oral placebo tablet arm 2: oral rabeprazole 10 mg enteric-coated tablet

[ 2, 0 ]

2

[ 0, 10 ]

intervention 1: Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase. intervention 2: Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.

intervention 1: rabeprazole sodium intervention 2: Placebo

1

Vista | California | United States | -117.24254 | 33.20004

0

NCT00236184

[ 4 ]

619

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn.

This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.

Heartburn

Heartburn Rabeprazole

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally,placebo once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase. intervention 2: Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.

intervention 1: rabeprazole sodium intervention 2: placebo

1

Lake Success | New York | United States | -73.71763 | 40.77066

0

NCT00236197

[ 3 ]

13

NA

SINGLE_GROUP

4SUPPORTIVE_CARE

0NONE

false

0ALL

true

RATIONALE: Voriconazole and caspofungin acetate may control invasive fungal infections in patients who have weakened immune systems. PURPOSE: This phase II trial is studying how well giving voriconazole together with caspofungin acetate works in treating invasive fungal infections in patients with weakened immune systems.

OBJECTIVES: Primary * Determine the 12-week complete and partial response rate in immunocompromised patients with invasive fungal infections treated with voriconazole and caspofungin acetate. Secondary * Determine the 12-week survival rate in patients treated with this regimen. * Determine the safety of this regimen in these patients. OUTLINE: Patients receive voriconazole orally or IV over 1 hour twice daily and caspofungin acetate IV over 1 hour once daily on days 1-84. Treatment continues in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Infection Unspecified Adult Solid Tumor, Protocol Specific

infection unspecified adult solid tumor, protocol specific

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84. intervention 2: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses. Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours (at least one hour before or after meals).

intervention 1: caspofungin acetate intervention 2: voriconazole

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT00238355

[ 3 ]

172

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to evaluate the efficacy of PI-88 to inhibit or reduce tumor recurrence in patients with hepatocellular carcinoma following hepatectomy.

Although early diagnosis and treatment improve survival, hepatocellular carcinoma (HCC) is rarely cured and recurs frequently after regional therapy or transplantation. Hepatic resection can improve 5-year recurrence-free survival by up to 25%. Micrometastases of HCC have been detected by molecular techniques in 88% of patients at the time of surgery, and probably cause postoperative recurrence. Efforts to reduce the risk of recurrence after a curative resection have been tried, including various regimens of adjuvant and neoadjuvant therapy. In this study , an anti-angiogenic agent, PI-88, is being used as an adjuvant therapy for HCC patients after curative hepatic resection. The efficacy endpoints, including tumour non-recurrence rate, time to first recurrence and 1-year survival rate are being evaluated. Several risk factors associated with tumour recurrence are also being analysed.

Carcinoma, Hepatocellular

PI-88 post resection hepatoma adjuvant therapy hepatectomy hepatoma

null

3

arm 1: Untreated control arm arm 2: PI-88 160 mg/day SC injection arm 3: PI-88 250 mg/day SC injection

[ 4, 0, 0 ]

1

[ 0 ]

intervention 1: Once-daily SC injection for four consecutive days per week, for 3 weeks out of every 4 weeks

intervention 1: PI-88

6

Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Tainan City | N/A | Taiwan | 120.21333 | 22.99083 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896

0

NCT00247728

[ 3 ]

80

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

null

The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and efficacy of reparixin in preventing the delayed graft function (DGF) after kidney transplantation.

Delayed graft function (DGF) is the most common allograft complication in the immediate kidney post-transplant period, affecting 25-35% of all patients who receive a cadaver graft, but rates up to 50% have been reported, especially in recipients of kidneys from marginal donors. It is an important clinical complication as it requires dialysis, prolongs hospitalisation, raises the cost of transplantation, and makes more difficult the management of immunosuppressive therapy. Although the effects of DGF on long-term graft function are still debated, there is overall increasing evidence that DGF reduces long-term graft survival. Moreover, given the well documented impact of acute rejection on long-term graft survival, it is conceivable that DGF and acute rejection synergize in negatively influencing long-term graft survival. Kidney reperfusion, after long cold ischemia period, is associated with an inflammatory reaction characterized by massive polymorphonuclear leukocyte (PMN) infiltration both at the glomerular and tubular levels. The importance of CXCL8 in recruiting PMN in kidney tissue during the ischemic time and after reperfusion has been clearly documented. The efficacy of reparixin in preventing PMN infiltration and tissue damage in rat models of kidney transplantation and lung transplantation, as well as the safety shown in human phase 1 studies, provide the rationale for a clinical study aimed at evaluating the effect of reparixin in preventing DGF after kidney transplantation

Ischemia-Reperfusion Injury Kidney Diseases

Kidney transplantation Reperfusion Injury Survival

null

3

arm 1: Continuous iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.772 mg/kg/h was administered for12 hours. arm 2: Intermittent iv infusion into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump. A dose of 2.244 mg/kg was administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were administered over a total period of 22.5 hours. arm 3: Continuous/intermittent iv infusion of a volume/schedule matched saline into a (high flow) central vein (or through an arterio-venous fistula) by an infusion pump.

[ 0, 0, 2 ]

3

[ 0, 0, 10 ]

intervention 1: The Investigational Product was administered as an intravenous infusion into a (high flow) central vein or through an arterio-venous fistula, by an infusion pump adequate to provide reliable infusion rates, as per treatment schedule. Total infusion volume did not exceed 500 mL/24 hours. A dose of 2.772 mg/kg body weight/hour was to be administered for 12 hours. Placebo was volume/schedule matched saline. intervention 2: A dose of 2.244 mg/kg body weight was to be administered over a 30-minute period, followed by a 1.5-hour interval. Twelve doses were to be administered over a total period of 22.5 hours. Placebo was volume/schedule matched saline. intervention 3: placebo was volume/schedule matched saline

intervention 1: Reparixin continuous infusion intervention 2: reparixin intermittent infusion intervention 3: placebo infusion

9

Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Montpellier | N/A | France | 3.87635 | 43.61093 Paris | N/A | France | 2.3488 | 48.85341 Bergamo | N/A | Italy | 9.66721 | 45.69601 Brescia | N/A | Italy | 10.21472 | 45.53558 Padua | N/A | Italy | 11.88586 | 45.40797 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879

0

NCT00248040

[ 5 ]

46

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study aims to examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low folate is associated with negative symptoms, and to examine the efficacy of folate supplementation for reducing negative symptoms.

This study is a three-month, placebo-controlled trial of folate 2mg/d in 50 schizophrenia patients who score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale. The specific aims of this study are: * To examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between patients at baseline, including dietary intake and cigarette smoking. * To test the hypothesis that low folate is associated with negative symptoms by examining correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients. We will also control for dietary intake cigarettes smoking, gender, and age. * To examine the efficacy of folate supplementation for reducing negative symptoms

Schizophrenia

Schizophrenia Negative Symptoms Folate

null

2

arm 1: Participants will receive a 2 mg/ day dose of folate, for 12 weeks arm 2: Participants will receive a 2 mg/ day dose of placebo, for 12 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Folic acid taken as 2, 1mg capsule daily for 12 weeks intervention 2: Placebo taken as 2, 1mg capsule daily for 12 weeks

intervention 1: Folate intervention 2: Placebo

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00249288

[ 4 ]

868

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to severe plaque-type psoriasis for at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may also be enrolled).

null

Psoriasis

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22. intervention 2: Methotrexate will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a \<25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.

intervention 1: infliximab intervention 2: methotrexate

0

null

0

NCT00251641

[ 5 ]

146

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This is an Australian, open-label, multicenter, randomized, double-blind clinical trial designed to assess the efficacy of combination therapy with pegylated interferon alfa-2b and ribavirin for 48 weeks versus 24 weeks in the treatment of chronic hepatitis C (treatment-naïve genotype 3 subjects with high viral loads who have a METAVIR score of at least F1A2). The primary endpoint will be a sustained virological response defined by undetectable HCV RNA in serum at 24 weeks after completion of therapy.

null

Hepatitis C, Chronic

chronic hepatitis C pegylated interferon alfa-2b ribavirin Australia

null

2

arm 1: Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks arm 2: Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks

[ 1, 0 ]

4

[ 2, 2, 0, 0 ]

intervention 1: Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks intervention 2: Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks intervention 3: 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 weeks intervention 4: 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks

intervention 1: Peginterferon alfa-2b intervention 2: Peginterferon alfa-2b intervention 3: Ribavirin intervention 4: Ribavirin

0

null

0

NCT00255034

[ 2, 3 ]

15

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine whether memantine is safe and effective when used as an augmentation to standard treatment for Obsessive-Compulsive Disorder (OCD).

The purpose of this study is to determine whether memantine (Namenda), in doses up to 20 mg/day, will be effective in treating the OCD of adult patients who have not responded to their OCD medication. Memantine is not FDA approved for OCD, but is approved for the treatment of Alzheimer's Disease. Memantine appears to work by regulating the activity of glutamate, one of the brain's specialized messenger chemicals, which may play a role in OCD. All patients in the study will receive memantine; no one will receive placebo.

Obsessive-Compulsive Disorder

null

1

arm 1: All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.

[ 0 ]

1

[ 0 ]

intervention 1: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder

intervention 1: Memantine

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00264238

[ 4 ]

22

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry tumor-killing substances, such as chemotherapy, directly into the liver. Giving chemotherapy in different ways may kill more tumor cells. It is not yet known whether giving oxaliplatin and capecitabine together with an hepatic arterial infusion with floxuridine is more effective than giving oxaliplatin and capecitabine alone in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer. PURPOSE: This randomized phase III trial is studying oxaliplatin, capecitabine, and an hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin and capecitabine in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.

OBJECTIVES: Primary * Compare progression-free interval (PFI) in patients undergoing surgical resection and/or ablation for hepatic metastases from colorectal cancer treated with adjuvant therapy comprising oxaliplatin and capecitabine with vs without hepatic arterial infusion of floxuridine. Secondary * Compare overall survival and liver PFI between the two treatment groups. * Assess toxicity in each of the treatment regimens. * Compare self-reported symptoms between two treatment groups. * Compare quality of life in each of the treatment regimens. Tertiary * Examine the prognostic worth, in terms of PFI, of specific molecular markers in hepatic metastases. OUTLINE: This is a randomized study. Patients are stratified according to intended surgical technique (surgical resection alone vs cryoablation or radiofrequency ablation \[RFA\] alone vs combination of resection and ablation) and prior adjuvant chemotherapy regimen (chemotherapy with vs without oxaliplatin vs no chemotherapy). Patients are randomized to 1 of 2 treatment arms. All patients undergo surgical resection and/or hepatic cryoablation or RFA to remove a maximum of 6 colorectal hepatic metastases. Patients randomized to arm II also undergo intra-arterial catheter and if applicable, pump placement. * Arm 1 (oxaliplatin and capecitabine): Within 4-6 weeks after surgery and/or ablation, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. * Arm 2 (oxaliplatin, capecitabine, and hepatic arterial infusion of floxuridine): Within 4-6 weeks after surgery and/or ablation, patients receive a continuous hepatic arterial infusion of floxuridine on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity. Beginning with course 5, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, 4-6 weeks after surgery or ablation, approximately 18 weeks after beginning of chemotherapy, and 4-6 weeks after beginning the last cycle of chemotherapy. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Colorectal Cancer Metastatic Cancer

liver metastases stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum

null

2

arm 1: Within 4-6 weeks after surgery and/or ablation, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. arm 2: Within 4-6 weeks after surgery and/or ablation, patients receive a continuous hepatic arterial infusion of floxuridine on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 42 days for 4 cycles in the absence of unacceptable toxicity. Beginning with cycle 5, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment with oxaliplatin and capecitabine repeats every 21 days for 4 cycles.

[ 1, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1 Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles: Arm 2 intervention 2: Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles intervention 3: Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1 Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles: Arm 2

intervention 1: capecitabine intervention 2: floxuridine intervention 3: oxaliplatin

31

0

NCT00268463